Methods and systems for high-throughput blood component collection

ABSTRACT

Described are embodiments that include methods and devices for separating components from multi-component fluids. Embodiments may involve use of separation vessels and movement of components into and out of separation vessels through ports. Embodiments may involve the separation of plasma from whole blood. Also described are embodiments that include methods and devices for positioning portions, e.g., loops, of disposables in medical devices. Embodiments may involve use of surfaces for automatically guiding loops to position them into a predetermined position.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a divisional application of and claimspriority to, U.S. patent application Ser. No. 17/392,804, entitled“Methods and Systems for High-Throughput Blood Component Collection,”filed on Aug. 3, 2021, which is a divisional application of and claimspriority to, U.S. patent application Ser. No. 15/958,851, entitled“Methods and Systems for High-Throughput Blood Component Collection,”filed on Apr. 20, 2018 now issued as U.S. Pat. No. 11,090,425, whichclaims the benefit of and priority, under 35 U.S.C. § 119(e), to U.S.Provisional Application Ser. No. 62/488,404, filed Apr. 21, 2017,entitled “Disposable Loading;” and 62/539,053, filed Jul. 31, 2017,entitled “Component Collection.” The entire disclosures of theapplications listed above are hereby incorporated by reference, in theirentirety as if set forth herein in full, for all that they teach and forall purposes.

FIELD

The present disclosure is generally directed to separating componentsfrom multi-component fluids, in particular, toward apheresis methods andsystems.

BACKGROUND

There are two common methods for blood donation/collection. The first iswhole blood donation from a donor, followed by a centrifugal processthat separates blood components from the whole blood based on thedensity of the blood component. The desired component can be manually,semi-automatically, or automatically moved to a collection containerduring, or possibly, after the whole blood is under the effect of theforces produced by the centrifuge. The other method may be an apheresiscollection that requires a specialized machine.

The apheresis method extracts whole blood from a donor while the donoris connected to the specialized machine. The whole blood can again becentrifuged to collect only the blood component (e.g., plasma) that isdesired and can return all other blood components not desired back tothe donor during the same donation. The donor is connected to theapheresis machine during the separation and collection of the bloodcomponent. Unfortunately, the apheresis process can be lengthy anduncomfortable. Often, the donor must remain connected to the machine foran hour to obtain a blood component donation. Thus, making the donationprocedure more efficient is an ongoing desire for apheresis collectionsites.

SUMMARY

There is a need for a plasma or other blood component system that canreduce the donation time and increase the comfort of the donor.Embodiments presented herein can increase the efficiency of the donationprocess by using the separated blood component to push or drive thenon-desired blood components back to the donor without stopping andrestarting the centrifuge. Thus, the embodiments herein make thedonation process more efficient and faster for the donor.

Embodiments may also provide methods and apparatuses for positioningportions, e.g., loops, of disposables in medical devices. Embodimentsmay involve use of surfaces for automatically guiding loops. In someembodiments, the medical devices may be blood separation machines, suchas apheresis machines.

The previously mentioned and other needs are addressed by the variousaspects, embodiments, and/or configurations of the present disclosure.Also, while the disclosure is presented in terms of exemplaryembodiments, it should be appreciated that individual aspects of thedisclosure can be separately claimed.

Embodiments include an assembly for separating a component from amulti-component fluid, the assembly comprising: a filler comprising achannel for holding a separation bladder of a disposable, wherein thechannel comprises two opposing walls; and a loop rotational positionguide comprising a plurality of bearings, the loop rotational positionguide holding a flexible loop of a disposable when the separationbladder is loaded in the channel.

Aspects of the above assembly include wherein the loop rotationalposition guide comprises a stop plate. Aspects of the above assemblyinclude wherein the flexible loop contacts the stop plate when held inthe loop rotational position guide. Aspects of the above assemblyinclude wherein the assembly is part of an apheresis machine. Aspects ofthe above assembly include wherein the assembly is connected to a rotorthat rotates the loop rotational position guide around an axis ofrotation. Aspects of the above assembly include wherein the plurality ofbearings comprises a plurality of pairs of roller bearings.

Embodiments include a centrifuge assembly, comprising: a centrifugehousing having an outer surface and an internal cavity, wherein thecentrifuge housing rotates about a rotation axis of the centrifugeassembly; a fluid separating body disposed at least partially within theinternal cavity of the centrifuge housing and configured to rotaterelative to the centrifuge housing about the rotation axis; and a fluidline loop arm attached to a portion of the centrifuge housing andrunning along a length of the outer surface of the centrifuge housing,the fluid line loop arm including a bearing set disposed at a pointalong the length of the outer surface, wherein the bearing set isconfigured to contact a tubing portion of an interconnected fluid lineloop and maintain the fluid line loop in an engaged position relative tothe centrifuge housing while allowing the fluid line loop to rotate inthe engaged position.

Aspects of the above centrifuge assembly include wherein the bearing setcomprises a pair of roller bearings. Aspects of the above centrifugeassembly include wherein the bearing set comprises a plurality of pairsof roller bearings. Aspects of the above centrifuge assembly includewherein the centrifuge assembly is part of an apheresis machine. Aspectsof the above centrifuge assembly include wherein the fluid line loop isaffixed to a static nonrotating portion of the apheresis machine at afirst end of the fluid line loop via a first positively-locatedconnector, and wherein the fluid line loop is interconnected to thefluid separating body within the internal cavity at a second end of thefluid line loop via a second positively-located connector. Aspects ofthe above centrifuge assembly include wherein the second end of thefluid line loop rotates with the fluid separating body. Aspects of theabove centrifuge assembly include wherein the fluid line loop isphysically and fluidly attached to a disposable fluid separation bladderat the second positively-located connector. Aspects of the abovecentrifuge assembly include wherein the fluid line loop comprises aplurality of lumens, and wherein the fluid separation bladder comprisesa first flexible sheet attached to a second flexible sheet forming afluid pathway, wherein a first portion of the fluid pathway is narrowcompared to a second portion of the fluid pathway.

Embodiments include a method for automatically loading a fluid line loopinto a centrifuge assembly, the method comprising: attaching the fluidline loop at a first end to a fluid separating body of the centrifugeassembly; and rotating the fluid separating body in a first rotationaldirection relative to a housing of the centrifuge assembly, whereinrotating the fluid separating body causes the fluid line loop to rotaterelative to the housing and guide into a channel of a loop arm attachedto a portion of the housing, wherein the channel includes bearingsdisposed in a bearing set attached to the loop arm, wherein the bearingshold the fluid line loop in a position relative to the housing as thecentrifuge assembly rotates.

Aspects of the above method include wherein the bearings contact aportion of the fluid line loop as the fluid line loop rotates inside thechannel in the position relative to the housing. Aspects of the abovemethod include wherein centrifuge housing rotates in the firstrotational direction at a first angular velocity about a rotation axisand the fluid separating body is caused to rotate at a different secondangular velocity about the rotation axis via a twisting force providedby the fluid line loop. Aspects of the above method include wherein thesecond angular velocity is substantially two times the first angularvelocity. Aspects of the above method include wherein the fluid lineloop is physically and fluidly attached to a disposable fluid separationbladder disposed at least partially within the fluid separating body.Aspects of the above method further comprising: attaching a second endof the fluid line loop to a rotationally fixed point of an apheresismachine; and rotating, via a rotor and motor assembly of the apheresismachine, the centrifuge assembly about the rotation axis relative to therotationally fixed point of the apheresis machine.

Embodiments include a method for collecting a blood component throughapheresis, the method comprising: drawing whole blood into a centrifugefrom a donor; spinning the centrifuge to cause centrifugal force to acton the whole blood to separate the whole blood into a least a firstblood component and a third blood component; separating a first bloodcomponent from the whole blood; extracting the first blood componentinto a container; detecting when a second blood component is beingextracted; and after the second blood component is detected and whilethe centrifuge continues to spin, forcing the separated first bloodcomponent back towards the centrifuge to move at least the third bloodcomponent from the centrifuge and back into the donor.

Aspects of the above method include wherein the first blood component isone or more of plasma, platelets, red blood cells and/or high hematocritblood. Aspects of the above method include wherein the second bloodcomponent is one or more of plasma, platelets, red blood cells and/orhigh hematocrit blood and the third blood component is one or more ofplasma, platelets, red blood cells and/or high hematocrit blood. Aspectsof the above method include wherein the first blood component is two ormore of plasma, platelets, red blood cells and/or high hematocrit blood.Aspects of the above method include wherein the centrifuge spins at afirst speed when separating the first blood component from the wholeblood. Aspects of the above method include wherein the centrifugecontinues to spin at the first speed when forcing the separated firstblood component back towards the centrifuge. Aspects of the above methodinclude wherein the centrifuge spins at a second speed when drawingwhole blood into the centrifuge from the donor. Aspects of the abovemethod include wherein the second speed is slower than the first speed.Aspects of the above method include wherein the first blood component isseparated from the whole blood in a blood component collection set thatis inserted into the centrifuge. Aspects of the above method includewherein the centrifuge includes a filler that spins a blood componentcollection bladder associated with the blood component collection set.Aspects of the above method include wherein the blood componentcollection bladder is inserted into a collection insert channel formedin the filler to hold the blood component collection bladder.

Embodiments include an apheresis system comprising: a first tube havinga lumen, fluidly associated with the needle, that moves whole blood froma donor through the lumen; a draw pump engaged with the first tube thatdraws the whole blood into a centrifuge from the donor; the centrifugethat spins to cause centrifugal force to act on the whole blood toseparate the whole blood into a least a first blood component and athird blood component; a blood component collection bladder, insertedinto the centrifuge and fluidly associated with the first tube, thatseparates the first blood component from the whole blood; a second tube,fluidly associated the blood collection bladder, that moves the firstblood component from the blood component collection bladder; acollection container, fluidly associated with the second tube, thatextracts the first blood component from the apheresis system; a sensorpositioned in physical proximity to the second tube to detect when asecond blood component is being extracted from the whole blood; andafter the second blood component is detected by the sensor and while thecentrifuge continues to spin, a return pump, engaged with the secondtube, that forces the separated first blood component back towards theblood component collection bladder through the second tube to move atleast the third blood component from the blood component collectionbladder and back into the donor.

Aspects of the above apheresis system include wherein the first bloodcomponent is plasma and the second blood component is platelets, redblood cells, and/or high hematocrit blood. Aspects of the aboveapheresis system further comprises an anticoagulant pump to drawanticoagulant from an anticoagulant bag and mix the anticoagulant withwhole blood at a manifold or junction fluidly associated with the firsttube. Aspects of the above apheresis system include wherein thecentrifuge includes a filler that spins the blood component collectionbladder. Aspects of the above apheresis system include wherein the bloodcomponent collection bladder is inserted into a collection insertchannel formed in the filler to hold the blood component collectionbladder.

Embodiments include a blood component collection set associated with anapheresis system comprising: a needle inserted into a blood vessel of adonor to draw whole blood from a donor; a first tube having a lumen,fluidly associated with the needle, that moves the whole blood throughthe lumen, wherein a draw pump engaged with the first tube draws thewhole blood from the donor; a blood component collection bladder,inserted into a centrifuge and fluidly associated with the first tube,that separates the first blood component and a third component from thewhole blood; a second tube, fluidly associated with the blood collectionbladder, that moves the first blood component from the blood componentcollection bladder; and a collection container fluidly associated withthe second tube that extracts the first blood component from theapheresis system, wherein a sensor is positioned in physical proximityto the second tube to detect when a second blood component is beingextracted from the whole blood; and wherein, after the second bloodcomponent is detected by the sensor and while the centrifuge continuesto spin, a return pump engaged with the second tube forces the separatedfirst blood component back towards the blood component collectionbladder through the second tube to move at least the third bloodcomponent from the blood component collection bladder and back into thedonor.

Aspects of the above blood component collection set include wherein thefirst blood component is plasma and the second blood component isplatelets. Aspects of the above blood component collection set includewherein the draw pump is disengaged when the return pump forces theseparated first blood component back towards the blood componentcollection bladder through the second tube to move at least the thirdblood component from the blood component collection bladder and backinto the donor. Aspects of the above blood component collection setinclude wherein the blood component collection bladder is inserted andheld in a filler, in the centrifuge, that spins the blood componentcollection bladder. Aspects of the above blood component collection setinclude wherein the blood component collection bladder is inserted intoa collection insert channel formed in the filler to hold the bloodcomponent collection bladder.

Embodiments include a filler for holding a separation bladder in which acomponent is separated from a composite fluid, the filler comprising: achannel for holding a separation bladder during separation of thecomponent from the composite fluid, the channel comprising: a firstwall; and a second wall opposite the first wall; and wherein a first endof the channel is adjacent a central portion of the filler and thechannel spirals toward an outside perimeter of the filler.

Aspects of the above filler include wherein a top portion of the channelis narrower than a middle portion of the channel. Aspects of the abovefiller include wherein at least a portion of the second wall has aconcave surface. Aspects of the above filler include wherein the secondend of the channel is located so that it experiences a highergravitational force during separation than the first end. Aspects of theabove filler include wherein the top portion of the channel providesreinforcement to the separation bladder during separation.

Embodiments include a fluid separation filler, comprising: a body havinga rotation axis substantially disposed at a mass center of the body; anda fluid collection insert channel disposed in the body and following asubstantially spiral path running from a first point adjacent to therotation axis spirally outward to a second point disposed adjacent to aperiphery of the body, wherein the fluid collection insert channel jogsoutwardly toward the periphery of the body near an end of thesubstantially spiral path defining a third point of the fluid collectioninsert channel disposed furthest from the rotation axis.

Aspects of the above fluid separation filler further comprise: a fluidcollection chamber disposed within the body and following a portion ofthe substantially spiral path, wherein the fluid collection insertchannel connects to the fluid collection chamber defining access areabetween an interior of the fluid collection chamber and an exterior ofthe body. Aspects of the above fluid separation filler include whereinthe fluid collection chamber is configured to receive a disposable fluidcollection bladder. Aspects of the above fluid separation filler includewherein a dimension from the rotation axis to the third point of thesubstantially spiral path is greater than a dimension from the rotationaxis to the second point of the substantially spiral path. Aspects ofthe above fluid separation filler include wherein a width of the fluidcollection chamber at a point along the substantially spiral path isgreater than a width of the fluid collection insert channel at the pointalong the substantially spiral path. Aspects of the above fluidseparation filler include wherein the fluid collection chamber furthercomprises a first wall following an innermost portion of thesubstantially spiral path and a second wall substantially parallel tothe first wall and following an outermost portion of the substantiallyspiral path. Aspects of the above fluid separation filler includewherein the fluid collection chamber further comprises one or moretapered walls disposed between the first wall and the second wall, andwherein the one or more tapered walls are configured to guide thedisposable fluid collection bladder into a seated position within thefluid collection chamber. Aspects of the above fluid separation fillerinclude wherein a fluid inlet for the disposable fluid collectionbladder when installed in the fluid collection chamber is disposedadjacent to the rotation axis and a first fluid path in the disposablefluid collection bladder follows the substantially spiral path outwardlytoward an end of the disposable fluid collection bladder disposedadjacent to the third point of the fluid collection insert channeldisposed furthest from the rotation axis, and fluidly interconnects witha second fluid path separated from the first fluid path in thedisposable fluid collection bladder running in a direction from thethird point following the substantially spiral path inwardly toward afluid outlet for the disposable fluid collection bladder disposedadjacent to the rotation axis. Aspects of the above fluid separationfiller include wherein the fluid inlet and the fluid outlet are part ofa connector attached to the disposable fluid collection bladder, andwherein the body of the fluid separation filler includes a connectionpoint that engages with the connector. Aspects of the above fluidseparation filler include wherein the connector includes at least onekey feature, wherein the connection point includes at least one matingkey feature, and wherein the key features positively locate theconnector relative to the connection point.

Embodiments include a centrifuge assembly, comprising: a centrifugehousing having an internal cavity, wherein the centrifuge housingrotates about a rotation axis of the centrifuge assembly; and a fluidseparating body disposed at least partially within the internal cavityof the centrifuge housing and configured to rotate relative to thecentrifuge housing about the rotation axis, wherein the fluid separatingbody includes a fluid collection insert channel disposed in the fluidseparating body following a substantially spiral path running from afirst point adjacent to the rotation axis spirally outward to a secondpoint disposed adjacent to a periphery of the fluid separating body,wherein the fluid collection insert channel jogs outwardly toward theperiphery of the body near an end of the substantially spiral pathdefining a third point of the fluid collection insert channel disposedfurthest from the rotation axis.

Aspects of the above centrifuge assembly include wherein the fluidseparating body further comprises a fluid collection chamber disposedwithin the body and following a portion of the substantially spiralpath, wherein the fluid collection insert channel connects to the fluidcollection chamber defining an access area between an interior of thefluid collection chamber and an exterior of the fluid separating body.Aspects of the above centrifuge assembly further comprise a disposablefluid collection bladder disposed within the fluid collection chamberfollowing the substantially spiral path, wherein the disposable fluidcollection bladder includes a fluid inlet disposed adjacent to therotation axis and a first fluid path in the disposable fluid collectionbladder follows the substantially spiral path outwardly toward an end ofthe disposable fluid collection bladder disposed adjacent to the thirdpoint of the fluid collection insert channel disposed furthest from therotation axis, and fluidly interconnects with a second fluid pathseparated from the first fluid path in the disposable fluid collectionbladder running in a direction from the third point following thesubstantially spiral path inwardly toward a fluid outlet for thedisposable fluid collection bladder disposed adjacent to the rotationaxis. Aspects of the above centrifuge assembly include wherein thecentrifuge assembly is part of an apheresis machine. Aspects of theabove centrifuge assembly include wherein the centrifuge housing issplit into an upper housing and a lower housing, wherein the upperhousing includes the internal cavity, wherein the upper housing isrotatable between an open state and a closed state about a pivot axisthat is offset and substantially perpendicular to the rotation axis, andwherein the fluid collection insert channel of the fluid separating bodyis accessible in the open state and inaccessible in the closed state.

Embodiments include a blood component collection loop comprising: aflexible loop; a system static loop connector disposed at a first end ofthe flexible loop, wherein the system static loop connector is connectedto the fixed loop connection of a centrifuge to fix the first end of theflexible loop to rotate in unison with the centrifuge; a filler loopconnector disposed at a second end, opposite the first end, of theflexible loop, wherein the filler loop connector is connected to a loopconnection area of a filler, and wherein torsional forces based on twistin the flexible loop are imparted to the filler through the filler loopconnector; and wherein flexible loop is rotationally moved to becaptured by a loop rotational position guide positioned on thecentrifuge.

Aspects of the above blood component collection loop include wherein theblood component collection loop is part of a blood component collectionset, and wherein the blood component collection set is associated withan apheresis system. Aspects of the above blood component collectionloop include wherein the loop rotational position guide is attached to arotor that rotates the loop rotational position guide and the flexibleloop around an axis of rotation. Aspects of the above blood componentcollection loop include wherein the blood component collection loop isat least partially positioned by a loop position stop plate. Aspects ofthe above blood component collection loop include wherein the flexibleloop is curved around the centrifuge. Aspects of the above bloodcomponent collection loop include wherein at the flexible loops is alsoheld in position by a loop containment bracket. Aspects of the aboveblood component collection loop include wherein at least a portion ofthe loop rotational position guide comprises a loop twist supportbearing. Aspects of the above blood component collection loop includewherein the loop twist support bearing comprises a pair of rollerbearings. Aspects of the above blood component collection loop includewherein the loop twist support bearing allows the flexible loop totwist. Aspects of the above blood component collection loop includewherein the twist causes the filler to rotate at a greater angularvelocity than the centrifuge. Aspects of the above blood componentcollection loop include wherein the flexible loop can contain two ormore lumens to move whole blood and/or blood components within theflexible loop.

Embodiments include an assembly for loading a flexible loop, theassembly comprising: a loop rotation position guide comprising a channelfor holding a flexible loop of a blood component collection set; a looptwist support bearing, disposed in the channel and on a portion of theloop rotation position guide, to support the flexible loop; and a loopcapture arm, wherein the loop capture arm is positioned adjacent thechannel and connected to the loop rotation position guide, to guide theflexible loop into the channel and in contact with the loop twistsupport bearing.

Aspects of the above assembly include wherein the assembly is part of anapheresis machine, and wherein the loop rotation position guide isattached to centrifuge that rotates the loop rotation position guide andthe flexible loop around an axis of rotation. Aspects of the aboveassembly include wherein the loop rotation position guide furtherincludes a loop position stop plate to further position the flexibleloop. Aspects of the above assembly further comprise a loop containmentbracket, positioned in a plane with the loop rotation position guide anddisposed on the centrifuge, to further capture the flexible loop.

Embodiments include a method for automatically loading a flexible loopinto an assembly, the method comprising: connecting a system static loopconnector, disposed at a first end of the flexible loop, to a fixed loopconnection of a centrifuge to fix the first end of the flexible loop torotate in unison with the centrifuge; connecting a filler loopconnector, disposed at a second end, opposite the first end, of theflexible loop, to a loop connection area of a filler, and whereintorsional forces based on twist in the flexible loop are imparted to thefiller through the filler loop connector; and rotationally moving theflexible loop into a loop rotational position guide positioned on thecentrifuge.

Aspects of the above method include wherein the flexible loop engages aloop twist support bearing, disposed in a channel formed by the looprotation position guide, wherein the loop twist support bearing supportsthe flexible loop. Aspects of the above method include wherein a loopcapture arm contacts the flexible loop when rotating to guide theflexible loop into the channel and in contact with the loop twistsupport bearing. Aspects of the above method include wherein the looprotation position guide further includes a loop position stop plate toprevent over-rotation of the flexible loop past the channel. Aspects ofthe above method include wherein a loop containment bracket, positionedin a plane with the loop rotation position guide and disposed on thecentrifuge, further captures and holds the flexible loop.

Embodiments include a soft cassette comprising: a first cassette port; asecond cassette port; a direct flow lumen fluidly connected to the firstcassette port and the second cassette port; a drip chamberinter-disposed in the direct flow lumen such that the fluid passingthrough the direct flow lumen passes through the drip chamber; and afluid flow bypass path both fluidly connected to the direct flow lumenadjacent the first cassette port and between the first cassette port andthe drip chamber and fluidly connected to the direct flow lumen adjacentthe second cassette port and between the second cassette port and thedrip chamber, such that fluid flowing through the fluid flow bypass pathbypasses the drip chamber.

Aspects of the above soft cassette include wherein the fluid flow bypasspath is comprised of a first bypass branch fluidly connected to thedirect flow lumen adjacent the first cassette port and a second bypassbranch fluidly connected to the direct flow lumen adjacent the secondcassette port. Aspects of the above soft cassette include wherein thefluid flow bypass path further comprises a fluid pressure annulusdisposed between and fluidly connected to the first bypass branch andthe second bypass branch. Aspects of the above soft cassette includewherein the direct flow lumen comprises a first compliant region,disposed between a first connection with the first bypass branch and thedrip chamber, that allows a first fluid control valve to occlude thedirect flow lumen. Aspects of the above soft cassette include whereinthe direct flow lumen comprises a second compliant region, disposedbetween a second connection with the second bypass branch and the dripchamber, that allows a second fluid control valve to occlude the directflow lumen. Aspects of the above soft cassette include wherein thedirect flow lumen comprises a third compliant region, disposed in thefirst bypass branch, that allows a draw fluid control valve to occludethe first bypass branch. Aspects of the above soft cassette includewherein the first cassette port is fluidly connected to a cassette inlettubing that moves fluid from a donor into the soft cassette or fluidfrom the soft cassette to the donor, and wherein the second cassetteport is fluidly connected to a loop inlet tubing that moves fluid from asoft cassette into the centrifuge or fluid from the centrifuge to thesoft cassette. Aspects of the above soft cassette include wherein, whendrawing fluid from the donor, the fluid passes through the fluid flowbypass path. Aspects of the above soft cassette include wherein, whensending fluid to the donor, the fluid passes through the direct flowlumen. Aspects of the above soft cassette include wherein, when drawingfluid from the donor in a subsequent draw, a portion of the fluidpreviously sent to the donor through the direct flow lumen is maintainedin the drip chamber when the fluid passes through the fluid flow bypasspath. Aspects of the above soft cassette include wherein the softcassette is part of a blood component collection set. Aspects of theabove soft cassette include wherein the blood component collection setis part of an apheresis system.

Embodiments include a blood component collection set, the bloodcomponent collection set comprising: a centrifuge to separate bloodcomponents from whole blood; a cassette inlet tubing fluidly connectedto a donor; a loop inlet tubing fluidly connected to the centrifuge; asoft cassette comprising: a first cassette port fluidly connected to thecassette inlet tubing; a second cassette port fluidly connected to theloop inlet tubing; a direct flow lumen fluidly connected to the firstcassette port and the second cassette port; a drip chamberinter-disposed in the direct flow lumen such that the fluid passingthrough the direct flow lumen passes through the drip chamber; and afluid flow bypass path both fluidly connected to the direct flow lumenadjacent the first cassette port and between the first cassette port andthe drip chamber and fluidly connected to the direct flow lumen adjacentthe second cassette port and between the second cassette port and thedrip chamber, such that fluid flowing through the fluid flow bypass pathbypasses the drip chamber.

Aspects of the above blood component collection set include wherein thefluid flow bypass path comprises: a first bypass branch fluidlyconnected to the direct flow lumen adjacent the first cassette port; asecond bypass branch fluidly connected to the direct flow lumen adjacentthe second cassette port; and a fluid pressure annulus disposed betweenand fluidly connected to the first bypass branch and the second bypassbranch. Aspects of the above blood component collection set includewherein the direct flow lumen comprises a first compliant region,disposed between a first connection with the first bypass branch and thedrip chamber, that allows a first fluid control valve to occlude thedirect flow lumen, wherein the direct flow lumen comprises a secondcompliant region, disposed between a second connection with the secondbypass branch and the drip chamber, that allows a second fluid controlvalve to occlude the direct flow lumen, and wherein the direct flowlumen comprises a third compliant region, disposed in the first bypassbranch, that allows a draw fluid control valve to occlude the firstbypass branch. Aspects of the above blood component collection setinclude wherein, when drawing fluid from the donor: the first fluidcontrol valve and the second fluid flow control valve are closed andocclude the direct flow lumen; and the draw fluid control valve is openand allows whole blood to pass through the fluid flow bypass path.Aspects of the above blood component collection set include wherein,when sending fluid to the donor: the first fluid control valve and thesecond fluid flow control valve are open and allow fluid to pass throughthe direct flow lumen; and the draw fluid control valve is closed andoccludes the fluid flow bypass path. Aspects of the above bloodcomponent collection set include wherein, when drawing fluid from thedonor in a subsequent draw, a portion of the fluid previously sent tothe donor through the direct flow lumen is maintained in the dripchamber when the fluid passes through the fluid flow bypass path.

Embodiments include a method for moving fluids through a soft cassettecomprising: providing a soft cassette, the soft cassette comprising: afirst cassette port fluidly connected to a cassette inlet tubing; asecond cassette port fluidly connected to a loop inlet tubing; a directflow lumen fluidly connected to the first cassette port and the secondcassette port; a drip chamber inter-disposed in the direct flow lumensuch that the fluid passing through the direct flow lumen passes throughthe drip chamber; and a fluid flow bypass path both fluidly connected tothe direct flow lumen adjacent the first cassette port and between thefirst cassette port and the drip chamber and fluidly connected to thedirect flow lumen adjacent the second cassette port and between thesecond cassette port and the drip chamber, such that fluid flowingthrough the fluid flow bypass path bypasses the drip chamber; whendrawing whole blood from a donor: receiving whole blood from thecassette inlet tubing at a first cassette port fluidly connected to thecassette inlet tubing; moving the whole blood through the fluid flowbypass path to the second cassette port; preventing whole blood frommoving through the direct lumen; when returning red blood cells to thedonor: receiving red blood cells from the loop inlet tubing at a secondcassette port fluidly connected to the loop inlet tubing; moving the redblood cells through the direct flow lumen and the drip chamber to thefirst cassette port; and preventing red blood cells from moving throughthe fluid flow bypass path.

Aspects of the above method include wherein, when drawing fluid from thedonor in a subsequent draw, a portion of the fluid previously sent tothe donor through the direct flow lumen, when returning red blood cellsto the donor, is maintained in the drip chamber when the whole bloodagain passes through the fluid flow bypass path.

Any one or more of the aspects/embodiments as substantially disclosedherein.

Any one or more of the aspects/embodiments as substantially disclosedherein. optionally in combination with any one or more otheraspects/embodiments as substantially disclosed herein.

One or more means adapted to perform any one or more of the aboveaspects/embodiments as substantially disclosed herein.

The present disclosure can provide a number of advantages depending onthe particular aspect, embodiment, and/or configuration. By maintainingthe speed of rotation of the centrifuge while moving the unneeded bloodcomponents back to the donor, the apheresis procedure can be reduced intime, possibly by 30% or more. This increase in efficiency allows forfaster and more comfortable donations. With faster donation times, adonation center can obtain more donations in a typical day, whichincreases productivity and revenue. Further, donors are more likely toreturn to donate again if the donation is faster. Having fasterdonations may also allow donation centers to attract donors using otherdonation centers with slower donation speeds.

These and other advantages will be apparent from the disclosure.

The phrases “at least one”, “one or more”, and “and/or” are open-endedexpressions that are both conjunctive and disjunctive in operation. Forexample, each of the expressions “at least one of A, B and C”, “at leastone of A, B, or C”, “one or more of A, B, and C”, “one or more of A, B,or C” and “A, B, and/or C” means A alone, B alone, C alone, A and Btogether, A and C together, B and C together, or A, B and C together.

The term “a” or “an” entity refers to one or more of that entity. Assuch, the terms “a” (or “an”), “one or more” and “at least one” can beused interchangeably herein. It is also to be noted that the terms“comprising”, “including”, and “having” can be used interchangeably.

The term “donor,” as used herein, can mean any person providing a fluid,e.g., whole blood, to the apheresis system. A donor can also be apatient that also provides a fluid to the apheresis system temporarilywhile the fluid is processed, treated, manipulated, etc. before beingprovided back to the patient.

The term “automatic” and variations thereof, as used herein, refers toany process or operation done without material human input when theprocess or operation is performed. However, a process or operation canbe automatic, even though performance of the process or operation usesmaterial or immaterial human input, if the input is received beforeperformance of the process or operation. Human input is deemed to bematerial if such input influences how the process or operation will beperformed. Human input that consents to the performance of the processor operation is not deemed to be “material”.

The term “computer-readable medium” as used herein refers to anytangible storage and/or transmission medium that participate inproviding instructions to a processor for execution. Such a medium maytake many forms, including but not limited to, non-volatile media,volatile media, and transmission media. Non-volatile media includes, forexample, NVRAM, or magnetic or optical disks. Volatile media includesdynamic memory, such as main memory. Common forms of computer-readablemedia include, for example, a floppy disk, a flexible disk, hard disk,magnetic tape, or any other magnetic medium, magneto-optical medium, aCD-ROM, any other optical medium, punch cards, paper tape, any otherphysical medium with patterns of holes, a RAM, a PROM, and EPROM, aFLASH-EPROM, a solid state medium like a memory card, any other memorychip or cartridge, a carrier wave as described hereinafter, or any othermedium from which a computer can read. A digital file attachment toe-mail or other self-contained information archive or set of archives isconsidered a distribution medium equivalent to a tangible storagemedium. When the computer-readable media is configured as a database, itis to be understood that the database may be any type of database, suchas relational, hierarchical, object-oriented, and/or the like.Accordingly, the disclosure is considered to include a tangible storagemedium or distribution medium and prior art-recognized equivalents andsuccessor media, in which the software implementations of the presentdisclosure are stored.

The term “module” as used herein refers to any known or later developedhardware, software, firmware, artificial intelligence, fuzzy logic, orcombination of hardware and software that is capable of performing thefunctionality associated with that element.

The terms “determine”, “calculate” and “compute,” and variationsthereof, as used herein, are used interchangeably and include any typeof methodology, process, mathematical operation or technique.

It shall be understood that the term “means” as used herein shall begiven its broadest possible interpretation in accordance with 35 U.S.C.,Section 112, Paragraph 6. Accordingly, a claim incorporating the term“means” shall cover all structures, materials, or acts set forth herein,and all of the equivalents thereof. Further, the structures, materialsor acts and the equivalents thereof shall include all those described inthe summary of the invention, brief description of the drawings,detailed description, abstract, and claims themselves.

The preceding is a simplified summary of the disclosure to provide anunderstanding of some aspects of the disclosure. This summary is neitheran extensive nor exhaustive overview of the disclosure and its variousaspects, embodiments, and/or configurations. It is intended neither toidentify key or critical elements of the disclosure nor to delineate thescope of the disclosure but to present selected concepts of thedisclosure in a simplified form as an introduction to the more detaileddescription presented below. As will be appreciated, other aspects,embodiments, and/or configurations of the disclosure are possibleutilizing, alone or in combination, one or more of the features setforth above or described in detail below

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a perspective view of an operating environment of anapheresis system in accordance with embodiments of the presentdisclosure;

FIG. 2A is a perspective view of the apheresis system shown in FIG. 1 ;

FIG. 2B is a first detail perspective view of a pump of an apheresissystem in accordance with embodiments of the present disclosure;

FIG. 2C is a second detail perspective view of a pump of an apheresissystem in accordance with embodiments of the present disclosure;

FIG. 2D is a detail perspective view of a fluid valve control system inaccordance with embodiments of the present disclosure;

FIG. 3A is a detail perspective view of a disposable soft cassetteassembly in accordance with embodiments of the present disclosure;

FIG. 3B is a perspective view of a disposable soft cassette inaccordance with embodiments of the present disclosure;

FIG. 3C is an elevation section view taken through line 3C of FIG. 3B;

FIG. 3D is an elevation section view taken through line 3D of FIG. 3B;

FIG. 4A shows a perspective view of a centrifuge assembly in anapheresis system in accordance with embodiments of the presentdisclosure;

FIG. 4B shows a front perspective view of the centrifuge assembly shownin FIG. 4A;

FIG. 4C shows a rear perspective view of the centrifuge assembly shownin FIG. 4A;

FIG. 4D is a schematic section view of a centrifuge assembly in a closedstate in accordance with embodiments of the present disclosure;

FIG. 4E is a schematic section view of a centrifuge assembly in apartially open state in accordance with embodiments of the presentdisclosure;

FIG. 4F is a schematic section view of a centrifuge assembly in an openstate in accordance with embodiments of the present disclosure;

FIG. 4G shows a perspective view of a filler for a centrifuge inaccordance with embodiments of the present disclosure;

FIG. 4H is a plan view of a filler for a centrifuge in accordance withembodiments of the present disclosure;

FIG. 4I is a schematic plan view of a substantially spiral-shapedreceiving channel for a filler in accordance with embodiments of thepresent disclosure;

FIG. 4J is an elevation section view taken through line 4J of FIG. 4H;

FIG. 4K is a detail section view of a portion of a channel in the fillerin accordance with embodiments of the present disclosure;

FIG. 4L shows different states of fluid collection bladders disposedinside the channel in the filler of FIG. 4K;

FIG. 5A shows a schematic view of a fluid component collection set inaccordance with embodiments of the present disclosure;

FIG. 5B shows an elevation view of a fluid component collection loop inaccordance with embodiments of the present disclosure;

FIG. 5C shows a cross-section of a bladder of a fluid componentcollection loop in accordance with one embodiment of the presentdisclosure;

FIG. 5D shows a cross-section of a bladder of a fluid componentcollection loop in accordance with another embodiment of the presentdisclosure;

FIG. 5E shows a perspective view of a fluid component collection loop ina flexed state in accordance with embodiments of the present disclosure;

FIG. 5F shows a perspective view of a fluid component collection loop ina loading state in accordance with embodiments of the presentdisclosure;

FIG. 5G shows a perspective view of a fluid component collection looploading into a filler in accordance with embodiments of the presentdisclosure;

FIG. 5H shows a perspective view of a fluid component collection looploaded in a filler in accordance with embodiments of the presentdisclosure;

FIG. 6A shows a schematic section view of a centrifuge assembly in afirst loop-loading state in accordance with embodiments of the presentdisclosure;

FIG. 6B shows a schematic section view of a centrifuge assembly in asecond loop-loading state in accordance with embodiments of the presentdisclosure;

FIG. 6C shows a schematic section view of a centrifuge assembly in athird loop-loading state in accordance with embodiments of the presentdisclosure;

FIG. 7A shows a schematic plan view of a centrifuge assembly in aloop-loaded state in accordance with embodiments of the presentdisclosure;

FIG. 7B shows a schematic plan view of a centrifuge assembly in anoperational state in accordance with embodiments of the presentdisclosure;

FIG. 8 is a functional diagram of an embodiment of the apheresis systemin accordance with embodiments of the present disclosure;

FIG. 9 is a block diagram of the electrical system of the apheresissystem in accordance with embodiments of the present disclosure;

FIG. 10 is a further block diagram of the electrical system of theapheresis system in accordance with embodiments of the presentdisclosure;

FIG. 11 is a further block diagram of the electrical system of theapheresis system in accordance with embodiments of the presentdisclosure;

FIG. 12 is a process diagram of a method for conducting apheresis inaccordance with embodiments of the present disclosure;

FIG. 13 is a process diagram of a method for conducting apheresis inaccordance with embodiments of the present disclosure;

FIG. 14 is a process diagram of a method for conducting apheresis inaccordance with embodiments of the present disclosure;

FIG. 15 is a process diagram of a method for conducting apheresis inaccordance with embodiments of the present disclosure;

FIG. 16 is a process diagram of a method for inserting a disposable intothe filler of the apheresis system in accordance with embodiments of thepresent disclosure;

FIG. 17A is a functional diagram of the apheresis system during anapheresis procedure in accordance with embodiments of the presentdisclosure;

FIG. 17B is another functional diagram of the apheresis system during anapheresis procedure in accordance with embodiments of the presentdisclosure;

FIG. 17C is another functional diagram of the apheresis system during anapheresis procedure in accordance with embodiments of the presentdisclosure;

FIG. 17D is another functional diagram of the apheresis system during anapheresis procedure in accordance with embodiments of the presentdisclosure;

FIG. 17E is another functional diagram of the apheresis system during anapheresis procedure in accordance with embodiments of the presentdisclosure;

FIG. 17F is another functional diagram of the apheresis system during anapheresis procedure in accordance with embodiments of the presentdisclosure;

FIG. 17G is another functional diagram of the apheresis system during anapheresis procedure in accordance with embodiments of the presentdisclosure;

FIG. 17H is another functional diagram of the apheresis system during anapheresis procedure in accordance with embodiments of the presentdisclosure;

FIG. 17I is another functional diagram of the apheresis system during anapheresis procedure in accordance with embodiments of the presentdisclosure;

FIG. 17J is another functional diagram of the apheresis system during anapheresis procedure in accordance with embodiments of the presentdisclosure;

FIG. 17K is another functional diagram of the apheresis system during anapheresis procedure in accordance with embodiments of the presentdisclosure;

FIG. 17L is another functional diagram of the apheresis system during anapheresis procedure in accordance with embodiments of the presentdisclosure;

FIG. 17M is another functional diagram of the apheresis system during anapheresis procedure in accordance with embodiments of the presentdisclosure;

FIG. 17N is another functional diagram of the apheresis system during anapheresis procedure in accordance with embodiments of the presentdisclosure;

FIG. 17O is another functional diagram of the apheresis system during anapheresis procedure in accordance with embodiments of the presentdisclosure;

FIG. 17P is another functional diagram of the apheresis system during anapheresis procedure in accordance with embodiments of the presentdisclosure;

FIG. 17Q is another functional diagram of the apheresis system during anapheresis procedure in accordance with embodiments of the presentdisclosure;

FIG. 17R is another functional diagram of the apheresis system during anapheresis procedure in accordance with embodiments of the presentdisclosure;

FIG. 17S is another functional diagram of the apheresis system during anapheresis procedure in accordance with embodiments of the presentdisclosure; and

FIG. 17T is another functional diagram of the apheresis system during anapheresis procedure in accordance with embodiments of the presentdisclosure.

In the appended figures, similar components and/or features may have thesame reference label. Further, various components of the same type maybe distinguished by following the reference label by a letter thatdistinguishes among the similar components. If only the first referencelabel is used in the specification, the description is applicable to anyone of the similar components having the same first reference labelirrespective of the second reference label.

DETAILED DESCRIPTION

Embodiments of the present disclosure will be described in connectionwith apheresis methods and systems. Embodiments below may be describedwith respect to separating blood components from whole blood. However,this example procedure is provided simply for illustrative purposes. Itis noted that the embodiments are not limited to the description below.The embodiments are intended for use in products, processes, devices,and systems for separating any composite liquid. Accordingly, thepresent disclosure is not limited to separation of blood components fromwhole blood.

Referring to FIG. 1 , a perspective view of an operating environment 100of an apheresis system 200 is shown in accordance with embodiments ofthe present disclosure. The operating environment 100 may include anapheresis system 200, a donor 102, and one or more connections (e.g.,donor feed tubing 104, cassette inlet tubing 108A, anticoagulant tubing110, etc.) running from the donor 102 to the apheresis system 200,and/or vice versa. As shown in FIG. 1 , donor feed tubing 104 may befluidly connected with at least one blood vessel, for example, a vein,of a donor 102 via venipuncture. For example, a cannula connected to anend of the donor feed tubing 104 may be inserted through the skin of thedonor 102 and into a target site, or vein. This connection may providean intravenous path for blood to flow from the donor 102 to theapheresis system 200, and/or for blood components to flow back to thedonor 102. In some embodiments, the fluid paths and connections may forman extracorporeal tubing circuit of the apheresis system 200.

Blood supplied from the donor 102 may flow along the donor feed tubing104 through a tubing connector 106 and along a cassette inlet tubing108A into a soft cassette assembly 300. The soft cassette assembly 300may include one or more fluid control paths and valves for selectivelycontrolling the flow of blood to and/or from the donor 102. Theapheresis system 200 may include an anticoagulant supply contained in ananticoagulant (AC) bag 114. The anticoagulant may be pumped at leastthrough anticoagulant tubing 110 and the tubing connector 106 preventingthe coagulation of blood in the apheresis system 200.

Anticoagulants can include one or more of, but are not limited to,citrate and/or unfractionated heparin. The AC bag and other bags orbottles described herein can be made from, for example, one or more of,but not limited to: polyvinyl chloride (PVC), plasticized-PVC,polyethylene, ethylene with vinyl acetate (EVA), rubber, silicone,thermoplastics, thermoplastic elastomer, polymers, copolymers, and/orcombinations thereof. The volume of AC in the AC bag 114 may vary basedon the various factors, including the mass of the donor 102, thevolumetric flow of blood from the donor, etc. In one example, the volumein the AC bag 114 may be 250 to 500 mL, although the volume in the ACbag 114 may be more or less than this volume.

In some embodiments, the apheresis system 200 may include a plasmacollection bottle 122, or container, a saline fluid contained in asaline bag 118, and one or more lines or tubes 116, 120 (e.g., fluidconveying tubing, etc.) connecting the saline bag 118 and the plasmacollection bottle 122 with the extracorporeal tubing circuit of theapheresis system 200. The amount of saline provided in the saline bag118 can be 500 to 800 mL, although the volume in the saline bag 118 maybe more or less than this volume. An example donation of a bloodcomponent, e.g., plasma, may be 880 mL. Thus, the plasma collectionbottle 122 may hold at least this amount of plasma. In some embodiments,the plasma collection bottle 122 may include a connection point disposedat, adjacent to, or in physical proximity to, a substantially bottommostportion of the plasma collection bottle 122 (e.g., when the plasmacollection bottle 122 is installed in the plasma collection cradle 232C,as shown in FIG. 2A). The connection point may include one or moreconnectors that are configured to interconnect with the plasma tubing120 to receive and/or convey plasma. The disposition of the connectionpoint at the bottom of the plasma collection bottle 122 can allow plasmacontained in the plasma collection bottle 122 to move out of the plasmatubing 120 back through the lines, as described herein, without trappingair bubbles, etc. In some embodiments, the plasma collection bottle 122may be configured as a flexible bag, rigid container, and/or othercontainer, and thus, the plasma collection bottle 122 is not limited tobottles or bottle-like containers.

FIG. 2A shows a perspective view of the apheresis system 200 describedin FIG. 1 . The apheresis system 200 may provide for a continuous wholeblood separation process. In one embodiment, whole blood may bewithdrawn from a donor 102 and substantially continuously provided to ablood component separation device of the apheresis system 200 where theblood may be separated into various components and at least one of theseblood components may be collected from the apheresis system 200. In someembodiments, one or more of the separated blood components may be eithercollected, for subsequent use, or returned to the donor 102. The bloodmay be withdrawn from the donor 102 and directed into a centrifuge ofthe apheresis system 200 through an opening 220 in an access panel 224of the apheresis system 200. In one embodiment, the tubing 104, 108A,108B, 112, 116, 120, used in the extracorporeal tubing circuit maytogether define a closed, sterile, and disposable system, or bloodcomponent collection set, which may be further described hereinafter.

Examples of apheresis, plasmapheresis, and other separation systems thatmay be used with embodiments of the present disclosure, e.g., asapheresis system 200, include, but are not limited to, the SPECTRAOPTIA® apheresis system, COBE® spectra apheresis system, and the TRIMAACCEL® automated blood collection system, all manufactured by TerumoBCT, of Lakewood, Colo.

Operation of the various pumps, valves, and blood component separationdevice, or centrifuge, may be controlled by one or more processorsincluded in the apheresis system 200, and may advantageously comprise aplurality of embedded computer processors that are part of a computersystem. The computer system may also include components that allow auser to interface with the computer system, including for example,memory and storage devices (RAM, ROM (e.g., CD-ROM, DVD), magneticdrives, optical drives, flash memory, etc.); communication/networkingdevices (e.g., wired such as modems/network cards, or wireless such asWi-Fi); input devices such as keyboard(s), touch screen(s), camera(s),and/or microphone(s); and output device(s) such as display(s), and audiosystem(s), etc. To assist the operator of the apheresis system 200 withvarious aspects of its operation, the embodiment of the blood componentseparation device, or centrifuge, may include a graphical user interfacewith a display that includes an interactive touch screen.

The apheresis system 200 may include a housing 204 and/or structuralframe, a cover 210, an access panel 224 disposed at a front 202 and/orrear 206 of the apheresis system 200, and one or more supports 232A-Cincluding hooks, rests, cradles, arms, protrusions, plates, and/or othersupport features for holding, cradling, and/or otherwise supporting abag or container 114, 118, 122. In some embodiments, the features of theapheresis system 200 may be described with reference to a coordinatesystem 103 and/or one or more axes thereof. The housing 204 may includea machine frame (e.g., made of welded, bolted, and/or connectedstructural elements, extruded material, beams, etc.) to which one ormore panels, covers 210, doors, subassemblies, and/or components areattached. In one embodiment, at least one panel of the apheresis system200 may include a mounting surface for the soft cassette assembly 300,one or more pumps 208, 212, 216, and/or a fluid valve control system 228(e.g., plasma and saline valve control, etc.).

The access panel 224 may include one or more handles, locks, and apivoting or hinged axis 226 (e.g., a door hinge, piano hinge, continuoushinge, cleanroom hinge, etc.). In any event, the access panel 224 may beselectively opened to provide access to an interior of the apheresissystem 200, and more specifically to a blood separation assembly, orcentrifuge. In one embodiment, the access panel 224 may provide accessto load and/or unload the centrifuge with one or more components in theblood component collection set. Details of the centrifuge are describedin greater detail at least with respect to FIGS. 4A-4L herein.

The inside of the apheresis system 200 may be separated into at least acentrifuge portion and a controls portion. For instance, the centrifugeportion may include a cavity configured to receive the centrifuge,rotation motor, and associated hardware. This area may be physicallyseparated from the controls portion via one or more walls of the cavity.In some embodiments, access to the controls portion (e.g., configured tohouse or otherwise contain the motor controller, CPU or processor(s),electronics, wiring, etc.) may be provided via a securely fastened panelof the housing 204, and/or panel separate from the access panel 224.

In some embodiments, the apheresis system 200 may include a number ofpumps 208, 212, 216 configured to control the flow of fluid (e.g., bloodand/or blood components, anticoagulant, saline, etc.) through theapheresis system 200. For instance, the apheresis system 200 may includea draw pump 208 that controls blood flow to and/or from the donor 102into the centrifuge of the apheresis system 200. The draw pump 208 mayengage with a portion of the loop inlet tubing 108B disposed between thesoft cassette assembly 300 and the centrifuge of the apheresis system200. In some embodiments, the apheresis system 200 may include a returnpump 212 configured to control a flow of separated blood components(e.g., plasma, etc.) from the centrifuge to a plasma collection bottle122 and/or vice versa. Additionally or alternatively, the return pump212 may control a flow of saline (e.g., supplied from a saline bag 118)throughout the blood component collection set and/or apheresis system200. The anticoagulant pump 216 may engage with a portion of theanticoagulant tubing 110 to selectively control the flow ofanticoagulant throughout the blood component collection set of theapheresis system 200. As shown in FIG. 2A, the pumps 208, 212, 216 canbe disposed at least partially on a top cover 210 of the apheresissystem 200.

FIGS. 2B and 2C show various perspective views of a pump 208, 212, 216of the apheresis system 200 in accordance with embodiments of thepresent disclosure. Although the draw pump 208 is shown and described inconjunction with FIGS. 2B and 2C, it should be appreciated that theother pump assemblies of the apheresis system 200, i.e., the return pump212 and the anticoagulant pump 216, may include a substantially similar,if not identical, construction to the draw pump 208 described.

The draw pump 208 may include a pump cover 236 or housing configured toat least partially enclose the moving elements of the draw pump 208. Insome embodiments, the pump cover 236 may include a hinged tubing guard240 that is configured to open and close about a tubing guard pivot axis242. In one embodiment, the tubing guard 240 may be attached to the pumpcover 236 via one or more fasteners disposed along the tubing guardpivot axis 242. As shown in FIGS. 2B and 2C, blood provided by a donor102 may be conveyed, or drawn, by the draw pump 208 into a centrifuge ina first draw or centrifuge direction 250A. Additionally oralternatively, blood or other fluid may be conveyed, or drawn, by thedraw pump 208 toward the donor 102 in a donor direction 250B, oppositethe centrifuge direction 250A.

In some embodiments, the draw pump 208 and/or other pumps 212, 216 maybe a tubing pump, peristaltic pump, diaphragm pump, and/or other pumpconfigured to manipulate the flow of fluid (e.g., blood, bloodcomponents, anticoagulant, saline, etc.) in at least a portion oftubing. For example, the pumps 208, 212, 216 may include a motoroperatively interconnected with a rotating tubing contact assembly. Inoperation, the tubing (e.g., loop inlet tubing 108B, loop exit tubing112, anticoagulant tubing 110, etc.) may be inserted into a lead tubingguide 244, a tubing pressure block 248, and an end tubing guide 252adjacent to the rotating tubing contact head. In one embodiment, thetubing pressure block 248 may be moved in a direction away from therotating tubing contact head or pump 208, 212, 216 providing a loadingclearance area, or vice versa. The rotating tubing contact head maycomprise a number of rotary pressure rollers 268 configured to rotateabout respective pressure roller rotation axes 264. Each of the rotarypressure rollers 268 may be disposed between a first rotary pump plate272A and a second rotary pump plate 272B, where the plates 272A, 272Bare configured to rotate about a pump rotation axis 260. In someembodiments, the rotary pressure rollers 268 may be disposed at aperiphery of the rotating pump plates 272A, 272B.

The one or more of the pumps 208, 212, 216 may include, or operatesimilarly to, the Pulsafeeder® model UX-74130 peristaltic pump,Pulsafeeder® MEC-O-MATIC series of pumps, all manufactured byPulsafeeder Inc., of Punta Gorda, Fla., without limitation. Otherexamples of pumps 208, 212, 216 may include, but are in no way limitedto, the INTEGRA DOSE IT laboratory peristaltic pump manufactured byINTEGRA Biosciences AG, of Switzerland, and WELCO WP1200, WP1100,WP1000, WPX1, and/or WPM series of peristaltic pumps all manufactured byWELCO Co., Ltd., of Tokyo, Japan.

Once the tubing is loaded into the lead tubing guide 244, the tubingpressure block 248, and/or the end tubing guide 252, at least some ofthe rotary pressure rollers 268 may be caused to engage with, contact,or otherwise compress the tubing disposed between the rotating tubingcontact head and the tubing pressure block 248. As the rotary pumpplates 272A, 272B rotate about the pump rotation axis 260 the rotarypressure rollers 268 may compress a portion of the tubing between thepump 208, 212, 216 and the tubing pressure block 248 positivelydisplacing fluid inside the portion of the tubing in a particulardirection 250A, 250B as the rotary pressure rollers 268 move. Forinstance, as the rotary pump plates 272A, 272B rotate in acounterclockwise direction about the pump rotation axis 260, therotation of the rotary pressure rollers 268 compressing the tubingbetween the rotary pressure rollers 268 and the tubing pressure block248 may displace, or pump, fluid in the centrifuge direction 250A. Asanother example, as the rotary pump plates 272A, 272B rotate in aclockwise direction about the pump rotation axis 260, the rotation ofthe rotary pressure rollers 268 compressing the tubing between therotary pressure rollers 268 and the tubing pressure block 248 maydisplace, or pump, fluid in the donor direction 250B. When not activelypumping, the pump 208 can be maintained in a state where at least onerotary pressure roller 268 continues to occlude the tubing 108B or in astate where no rotary pressure roller 268 occludes the tubing 108B.Thus, the pump 208, based on the state when motionless, can also act asa “valve” to prevent or allow fluid movement. This ability may also beavailable with pumps 212 and 216.

The tubing guard 240 and the pump cover 236 may serve to protect anoperator (e.g., phlebotomist, apheresis technician, etc.) and/or donor102 from incidental contact with one or more moving parts of the pumps208, 212, 216. In one embodiment, the tubing guard 240 may be held in aclosed position via one or more guard closure features 254 disposed inthe tubing guard 240, the lead tubing guide 244, tubing pressure block248, and/or the end tubing guide 252. In some cases, these guard closurefeatures 254 may be magnets contained in the tubing guard 240, the leadtubing guide 244, tubing pressure block 248, and/or the end tubing guide252. In some embodiments, the pump 208, 212, 216 may be stopped orprevented from moving/operating when the tubing guard 240 is open. Inthis embodiment, a guard closed sensor may be included in the guardclosure feature 254, the guides 244, 252, and/or the tubing pressureblock 248.

One or more fluid control valves may be used to control the routing orflow direction of fluid conveyed throughout the tubing of the apheresissystem 200. In some embodiments, the apheresis system 200 may include aplasma and saline valve control system 228 disposed adjacent to thesaline bag 118 and/or the plasma collection bottle 122. The plasma andsaline valve control system 228 is shown in the detail perspective viewof FIG. 2D.

As shown in FIG. 2D, the loop exit tubing 112 may pass through thereturn pump 212 and interconnect with a saline and plasma tubingy-connector 280. The saline and plasma tubing y-connector 280 may allowconnection of the loop exit tubing 112 to a saline tubing 116 line and aplasma tubing 120 line. The plasma and saline valve control system 228may include an air detection sensor 284 disposed at a first end of thesaline and plasma valve housing 276 and surrounding a portion of theloop exit tubing 112. The air detection sensor 284 can be any light,ultrasonic, or other type of sensor that can detect the presence offluid or air in the loop exit tubing 112 and provide that signal to acontroller of the apheresis system 200. Types of air detection sensors284 can include, for example, the SONOCHECK ABD05, made by SONOTEC USInc., or another similar sensor.

The saline and plasma valve housing 276 may include a number ofreceiving features (e.g., grooves, channels, receptacles, etc.) thatreceive a portion of tubing 112, 116, 120, and/or the saline and plasmatubing y-connector 280. Upon detecting air in the loop exit tubing 112,the plasma and saline valve control system 228 may selectively actuateone or more of the fluid control valves 286, 288. In some embodiments,the detection of air via the air detection sensor 284 may be used tosignal an operation step and/or trigger a step in a control method asdescribed herein.

The plasma flow control valve 286 and/or the saline flow control valve288 may be a solenoid valve, linear actuator, pinch valve, clamp valve,tubing valve, and/or other actuatable valve configured to selectivelyalter, e.g., occlude, a fluid passage associated with a particularportion of tubing 112, 116, 120. As shown in FIG. 2D, the plasma flowcontrol valve 286 may be configured to pinch a portion of the plasmatubing 120 at least partially contained in a receiving feature of thesaline and plasma valve housing 276. The saline flow control valve 288may be configured to pinch a portion of the saline tubing 116 at leastpartially contained in a receiving feature of the saline and plasmavalve housing 276. In any event, the control valves 286, 288 may includean actuatable extendable finger that moves from a retracted, orpartially retracted, position to an extended, or partially extended,position to pinch the portion of tubing contained in the saline andplasma valve housing 276. While the control valves 286, 288 maycompletely pinch the tubing (e.g., completely restricting fluid flowtherethrough), it should be appreciated that the control valves 286, 288may be partially actuated to a position that partially restricts fluidflow through a portion of the tubing.

Referring now to FIG. 3A, a detail perspective view of a disposable softcassette assembly 300 is shown in accordance with embodiments of thepresent disclosure. The soft cassette assembly 300 may include abaseplate and a cassette access door 304 that is attached to thebaseplate via at least one hinge and/or cassette access door latch 308.In some embodiments, the cassette access door 304 may be unlocked viaactuating the cassette access door latch 308 and pivoted about acassette access door hinge axis 306. The soft cassette assembly 300 maybe configured with one or more soft cassette receiving features 324 forat least partially containing and/or locating a soft cassette 340therein. The soft cassette 340 may be a part of the blood componentcollection set described herein. For instance, the soft cassette 340 maybe disposed between the cassette inlet tubing 108A and the loop inlettubing 108B of the extracorporeal tubing circuit. In some embodiments,the soft cassette 340 may provide one or more features for controllingthe flow of blood and/or blood components from a donor 102 to theapheresis system 200, and/or vice versa.

The soft cassette assembly 300 may include an air detection sensor 312,a fluid sensor 316, and one or more fluid control valves 320A-Cconfigured to control a routing or flow direction of fluid through thesoft cassette 340. In some embodiments, these components may be embeddedin the cassette access door 304, the baseplate, and/or a portion of thehousing 204 of the apheresis system 200. Similar to the guard closurefeature 254 described in conjunction with FIGS. 2B-2C, the soft cassetteassembly 300 may include one or more door closure features 328. Thesefeatures 328 may include, but are not limited to, magnetic catches,protrusions, tabs and slots, and/or other connections. In oneembodiment, the door closure features 328 may include pressure contactsurfaces configured to hold or at least partially position a softcassette 340 inside the soft cassette assembly 300.

Examples of the valves 320A-C may include, but are in no way limited to,a solenoid valve, linear actuator, pinch valve, clamp valve, tubingvalve, and/or other actuatable valve configured to selectively alter,e.g., occlude, a fluid passage (e.g., cross-sectional area, etc.)associated with a particular portion of the soft cassette 340. The softcassette assembly 300 may include a first fluid control valve 320Aconfigured to pinch a portion of the soft cassette 340 adjacent to acassette inlet tubing 108A. The second fluid control valve 320B may beconfigured to pinch a portion of the soft cassette 340 adjacent to theloop inlet tubing 108B. A draw fluid control valve 320C may beconfigured to pinch a portion of the soft cassette 340 along a branchtubing extending from a point adjacent to the cassette inlet tubing 108Ato a point adjacent to the loop inlet tubing 108B. In any event, thevalves 320A-C may include an actuatable extendable finger that movesfrom a retracted, or partially retracted, position to an extended, orpartially extended, position to pinch the portion of the soft cassette340 contained in the soft cassette assembly 300. While the valves 320A-Cmay completely pinch flow paths in the soft cassette 340 (e.g.,completely restricting fluid flow therethrough), it should beappreciated that the valves 320A-C may be partially actuated to aposition that partially restricts fluid flow through a portion of thesoft cassette 340.

The sensors 312, 316 may be one or more of an ultrasonic detector,pressure sensor, magnetic position sensor, and/or the like. In somecases, the fluid sensor 316 may determine whether fluid is present inthe soft cassette 340 based on a position of a magnet relative to aportion of the soft cassette 340. For instance, when the portion of thesoft cassette 340 is filled with a fluid, the magnet may be disposed ata first position from a surface of the soft cassette 340. On the otherhand, when the portion of the soft cassette 340 is filled with air, theforce from the magnet may compress the portion of the soft cassette 340to a second position closer to the surface of the soft cassette 340 thanthe first position. In any event, the detection of air or fluid via theair detection sensor 312 and the fluid sensor 316, respectively, may beused to signal an operation step and/or trigger a step in a controlmethod as described herein.

FIGS. 3B-3D show various views of a soft cassette 340 in accordance withembodiments of the present disclosure. As provided above, the softcassette 340 may be part of the blood component collection set. Forinstance, the soft cassette 340 may be a disposable component used inthe blood separation methods described herein. In some embodiments, thesoft cassette 340 may be made from a substantially compliant and/orflexible material. The compliant material may be chemically inert and/orbe capable of withstanding sterilization and cleaning operations,temperatures, and/or treatments. The soft cassette 340 may be made frompolyvinyl chloride (PVC), plasticized-PVC, polyethylene, ethylene withvinyl acetate (EVA), rubber, silicone, thermoplastics, thermoplasticelastomer, polymers, copolymers, and/or combinations thereof. In someembodiments, the soft cassette 340 may be molded, rotomolded, cast,injection molded, or otherwise formed from one or more of the materialsdescribed above.

The soft cassette 340 may include a first cassette port 360A, a secondcassette port 360B, and a direct flow lumen 370 running between thefirst and second cassette ports 360A-B. In some embodiments, the firstand/or second cassette ports 360A-B may be configured to receive and/orfluidly couple with one or more tubes of the blood component collectionset. For example, the first cassette port 360A may couple with thecassette inlet tubing 108A and the second cassette port 360B may couplewith the loop inlet tubing 108B. These couplings may be air and/or fluidtight. In one embodiment, the first and/or second cassette ports 360A-Bmay include an aperture disposed within the soft cassette 340 that isconfigured to elastically stretch around an end of the tubing (e.g.,cassette inlet tubing 108A, loop inlet tubing 108B, etc.).

Blood supplied by the donor 102 may be directed along one or more fluidpaths disposed within the soft cassette 340. In one embodiment, theblood may be directed along the direct flow lumen 370 from the firstcassette port 360A to the second cassette port 360B. In someembodiments, this flow path may direct the blood through the dripchamber 354 of the soft cassette 340. In some embodiments, blood and/orother fluids returned to the donor 102 may be directed along the directflow lumen 370 from the second cassette port 360B to the first cassetteport 360A.

The soft cassette 340 may include a fluid flow bypass path provided by afirst bypass branch 358A having a bypass flow lumen 364 that is fluidlyconnected to a portion of the direct flow lumen 370 adjacent to thefirst cassette port 360A or as part of the first cassette port 360A. Insome embodiments, the bypass flow lumen 364 may run from a point of thedirect flow lumen 370 adjacent to the first cassette port 360A, alongthe first bypass branch 358A, through a fluid pressure annulus 362 to asecond bypass branch 358B, and then reconnect to the direct flow lumen370 at a point adjacent to the second cassette port 360B or as part ofthe second cassette port 360B. As the name suggests, the bypass flowlumen 364 provides a flow path within the soft cassette 340 thatbypasses the drip chamber 354.

Controlling the flow path, or directing fluid, within the soft cassette340 may include actuating the fluid control valves 320A-C of the softcassette assembly 300 to interact with various compliant regions 350A-Cblocking and/or opening portions of the direct flow lumen 370 and/orbypass flow lumen 364. The first compliant region 350A provides a pinchvalve area at a point along the direct flow lumen 370 between the firstcassette port 360A and the drip chamber 354 near a first cassette end342 of the soft cassette 340. When the first fluid control valve 320A isactuated, the valve 320A may pinch the direct flow lumen 370 closed atthis first compliant region 350A, restricting or completely preventingthe flow of fluid at this point in the soft cassette 340. The secondcompliant region 350B provides a pinch valve area at a point along thedirect flow lumen 370 between the second cassette port 360B and the dripchamber 354 near a second cassette end 346 (e.g., opposite the firstcassette end 342). When the second fluid control valve 320B is actuated,the valve 320B may pinch the direct flow lumen 370 closed at this secondcompliant region 350B, restricting or completely preventing the flow offluid at this point in the soft cassette 340. As can be appreciated, thethird compliant region 350C disposed along the first bypass branch 358Aadjacent to the fluid pressure annulus 362 may provide a pinch valvearea at a point along the bypass flow lumen 364. When the draw fluidcontrol valve 320C is actuated, the valve 320C may pinch the bypass flowlumen 364 closed at this third compliant region 350C, restricting orcompletely preventing the flow of fluid through the bypass flow lumen364.

As shown in the elevation section view of FIG. 3C, taken through a planerunning through the direct flow lumen 370 and drip chamber 354, thedirect flow lumen 370 runs from the first cassette port 360A through theinner chamber volume 374 of the drip chamber 354 to the second cassetteport 360B. The direct flow lumen 370 may be formed as a fluid passagerunning inside the first tubing section 368A, the inner chamber volume374, and the second tubing section 368B of the soft cassette 340.

In some embodiments, the bypass path of the soft cassette 340 mayinclude a fluid pressure annulus 362 through which fluid can flow fromthe first bypass branch 358A to the second bypass branch 358B, and/orvice versa. In one embodiment, a pressure diaphragm 380 may be formed inthe material of the soft cassette 340 an area within, or adjacent to,the fluid pressure annulus 362. The fluid pressure annulus 362 andpressure diaphragm 380 are illustrated in the elevation section view ofFIG. 3D taken through a plane running through the fluid pressure annulus362 and a portion of the first and second bypass branches 358A-B. Thepressure diaphragm 380 may provide a contact, or measurement, surfacefor the fluid sensor 316 to detect whether the fluid pressure annulus362 and/or the bypass flow lumen 364 includes an amount of fluid, air,and/or combinations thereof. As provided above, as fluid fills a portionof the fluid pressure annulus 362, the fluid may provide greaterresistance to movement than when the fluid pressure annulus 362 isfilled with air. This difference in resistance may be measured via thefluid sensor 316 to determine, among other things, an amount and/or typeof fluid (e.g., air, blood, etc.) in the bypass flow lumen 364 and/orthe fluid pressure annulus 362.

FIG. 4A shows a perspective view of a centrifuge assembly 400 of theapheresis system 200 in accordance with embodiments of the presentdisclosure. The centrifuge assembly 400 may be disposed in an interiorspace of the apheresis system 200. The interior space may be at leastpartially enclosed with one or more elements of the housing 204 and/orcentrifuge chamber. Access to the interior space and the centrifugeassembly 400 may be provided via the access panel 224 disposed at thefront 202 of the apheresis system 200. For example, the access panel 224of FIG. 4A is shown in an open position, opened along hinged axis 226.As provided above, the hinged axis 226 may correspond to a door hinge,continuous hinge, cleanroom hinge, and/or some other panel hinge.

The centrifuge assembly 400 may be operatively mounted inside theapheresis system 200 such that the assembly 400 is capable of rotatingrelative to the housing 204 and/or other elements of the apheresissystem 200. The centrifuge assembly 400 may be loaded with one or moreportions of the blood component collection set by routing tubing (e.g.,loop inlet tubing 108B and loop exit tubing 112, etc.) into the interiorspace of the apheresis system 200 (e.g., via the opening 220 shown inFIG. 2A), connecting a portion of the blood component collection loop520 to the fixed loop connection 402 and inserting the blood componentcollection bladder 536 into a filler 460. The fixed loop connection 402maintains the loop inlet tubing 108B and the loop exit tubing 112 in afixed position and may prevent twisting of the tubing 108B, 112 outsideof the apheresis system 200. In some embodiments, the blood componentcollection loop 520 may be interconnected to the fixed loop connection402 via one or more keyed features or positive location features.

FIGS. 4B-4C show various perspective views of the centrifuge assembly400 separate from the apheresis system 200 for the sake of clarity indescription. The centrifuge assembly 400 may include a centrifugesplit-housing 404 comprising a lower housing 404A pivotally connected toan upper housing 404B. The upper housing 404B may open to provide accessfor loading a blood component collection bladder or other component ofthe blood component collection set into the centrifuge assembly 400. Insome embodiments, the upper housing 404B may pivot about thesplit-housing pivot axis 406 (e.g., configured as a hinge, pin,fastener, shoulder bolt, etc.).

The different halves (e.g., the lower housing 404A and upper housing404B) of the centrifuge split-housing 404 may be configured to lockand/or unlock together. Unlocking the upper housing 404B from the lowerhousing 404A may provide access to an interior of the centrifugeassembly 400. This selective locking may be achieved by rotating theupper housing 404B relative to the lower housing 404A about thecentrifuge rotation axis 430. Although the centrifuge split-housing 404is shown in FIGS. 4B-4C in an unlocked state, it should be appreciatedthat the upper housing 404B can be rotated (e.g., in a counterclockwisedirection) about the centrifuge rotation axis 430 to engage one or morelocking tabs 428 or elements of the upper housing 404B with lockingslots 432 disposed in the lower housing 404A (as shown in FIG. 4C). Whenin the unlocked position, the upper housing 404B may be opened, orpivoted, about the split-housing pivot axis 406 to load the centrifugeassembly 400 with a blood component collection loop 520 and/or a bloodcomponent collection bladder 536. When in the locked position, the upperhousing 404B is rotationally locked relative to the lower housing 404A,and the two halves of the centrifuge split-housing 404 may spintogether, locked in unison, during a centrifuge or blood separationoperation.

The centrifuge assembly 400 may include at least one clockwise rotationstop 408A, counterclockwise rotation stop 408B, upper housing clockwiserotation flag 410A, and/or upper housing counterclockwise rotation flag410B. In some embodiments, the rotation stops 408A, 408B may berotationally fixed relative to the centrifuge rotation axis 430 of thelower housing 404A. The rotation flags 410A, 410B may be attached, orformed in, the upper housing 404B and configured to contact respectiverotation stops 408A, 408B to prevent over-rotation of the upper housing404B relative to the lower housing 404A when locking and/or unlockingthe two halves of the centrifuge split-housing 404 together. Forinstance, upon rotating the upper housing 404B in a clockwise, orunlocking, direction about the centrifuge rotation axis 430, a portionof the upper housing clockwise rotation flag 410A may contact theclockwise rotation stop 408A preventing further rotation in theclockwise direction. Additionally or alternatively, upon rotating theupper housing 404B in a counterclockwise, or locking, direction aboutthe centrifuge rotation axis 430, a portion of the upper housingcounterclockwise rotation flag 410B may contact the counterclockwiserotation stop 408B preventing further rotation in the counterclockwisedirection. In some embodiments, the centrifuge split-housing 404 mayinclude one or more locking elements configured to maintain the halvesof the centrifuge split-housing 404 in a locked state, while the lockingelements are engaged.

In one embodiment, the centrifuge split-housing 404 may include a pullring 412 attached to a portion of the upper housing 404B to pivot theupper housing 404B relative to the lower housing 404A about thesplit-housing pivot axis 406. The pull ring 412 may provide an aperture,through which a user may insert a finger and apply a pull force to arotationally unlocked upper housing 404B.

The centrifuge assembly 400 may include a rotor and motor assembly 414that is controlled and/or powered via electrically interconnectedelectrical cabling 420. The electrical cabling 420 may include aconnector that attaches to a controller, processor, and/or power supply.This electrical cabling 420 may convey power and/or data signals betweenthe rotor and motor assembly 414 and one or more controllers/processorsof the apheresis system 200. The rotor and motor assembly 414 may beconfigured as an electric motor and/or portions of an electric motorthat rotate the complete centrifuge assembly 400 relative to theapheresis system 200 (e.g., relative to a portion of the housing 204and/or base of the apheresis system 200). In other words, the rotor andmotor assembly 414 may include one or more components that cause thecentrifuge assembly 400 (e.g., both halves of the centrifugesplit-housing 404 together) to rotate inside the apheresis system 200.

As described herein, the centrifuge assembly 400 may include one or morefeatures to guide, contain, and/or position elements of the bloodcomponent collection set relative to the centrifuge split-housing 404.For instance, in FIG. 4B, the blood component collection loop 520 isshown captured in an operational position in a loop rotational positionguide 424 comprising a loop capture arm 416. The loop rotationalposition guide 424 may include a number of bearings 417, and/or bearingsurfaces, arranged to at least partially support the blood componentcollection loop 520 in an operational position. In the operationalposition, the blood component collection loop 520 may twist along itslength within the support provided by the bearings 417 of the looprotational position guide 424. For example, the blood componentcollection loop 520 may be fixedly attached at one end to the fixed loopconnection 402 of the apheresis system 200 while the other end of theblood component collection loop 520 may be attached to a filler 460(e.g., the inner rotating component of the centrifuge assembly 400. Asthe centrifuge assembly 400 spins during a centrifuge operation, thetwisting of the blood component collection loop 520 between the fixedloop connection 402 and the connection at the filler 460 may cause thefiller 460 to rotate relative to the centrifuge split-housing 404 of thecentrifuge assembly 400. In one embodiment, the low inertia of thefiller 460 coupled with the twisting of the blood component collectionloop 520 as the centrifuge assembly 400 rotates in the apheresis system200, may cause the filler 460 to rotate at two times the angularvelocity of the centrifuge split-housing 404 in the same direction ofspin. In this example, when the centrifuge split-housing 404 spins in acounterclockwise direction about the centrifuge rotation axis 430 at afirst angular velocity, 1ω, the filler 460 may spin inside thecentrifuge split-housing 404 in the counterclockwise direction at asecond angular velocity, 2ω (e.g., substantially two times the firstangular velocity, etc.).

The centrifuge assembly 400 may include one or more balancing features,elements, and/or structures disposed about the centrifuge rotation axis430 of the centrifuge assembly 400. These balancing features may providean axially balanced centrifuge assembly 400, such that when spun on thecentrifuge rotation axis 430, the centrifuge assembly 400 may impartsubstantially no vibration to the apheresis system 200. In oneembodiment, a centrifuge balance weight 418 may be attached to a portionof the centrifuge split-housing 404 (e.g., the lower housing 404A and/orthe upper housing 404B, etc.). This centrifuge balance weight 418 may becustom tuned for the centrifuge assembly 400 and as such may beselectively attached and removed from the centrifuge assembly 400. Thetuning of the centrifuge balance weight 418 may be calculated and/orempirically derived to produce a completely balanced centrifuge assembly400, especially when loaded with one or more elements of the bloodcomponent collection set.

FIG. 4C shows a rear perspective view of the centrifuge assembly 400 inaccordance with embodiments of the present disclosure. A portion of thefiller 460 is visible through an aperture in the upper housing 404B. Theblood component collection loop 520 is shown in an initial loop loadingposition 520A, where a first end is interconnected with the filler 460and a second end is fixedly attached to the fixed loop connection 402(not shown). The blood component collection loop 520 is shown passingthrough a loop access clearance 436 in the centrifuge split-housing 404.When the blood component collection loop 520 is loaded in the looploading position 520A a portion of the blood component collection loop520 may be partially contained, held, and/or supported by a loopcontainment bracket 426. The loop containment bracket 426 may includeone or more bearings 417 (e.g., roller bearings, ball bearings, needlebearings, etc., and/or assemblies thereof, etc.), or bearing surfaces,arranged to at least partially support the blood component collectionloop 520 as it twists relative to the centrifuge assembly 400. In someembodiments, the blood component collection loop 520 may rotate about anaxis running along the length of the flexible loop 524 (e.g., in ainstalled or mounted condition and/or state, etc.) allowing for relativerotational motion of the flexible loop 524 to the loop rotationalposition guide 424. For instance, the loop does not “twist up” butactually rotates, or rolls, relative to the loop rotational positionguide 424 (e.g., support structure) in between one or more bearings 417.This rotation or torsion, without binding or twisting up the flexibleloop 524, may be referred to herein as a twist. The twist allows theflexible loop 524 to transmit rotational force to the filler 460 withouta substantial reduction in the inside diameter of the lumen of theflexible loop 524. In some cases, there is no reduction in the insidediameter of the lumen of the flexible loop 524.

As described above, when the upper housing 404B is rotated from therotationally unlocked position shown in FIGS. 4B-4C, to a rotationallylocked position, the locking tab 428 of the upper housing 404B mayengage with the locking slot 432 in the lower housing 404A. Additionallyor alternatively, when moved into the rotationally locked position, theloop containment bracket 426 may rotate, along with the blood componentcollection loop 520 and the upper housing 404B, to a position in-linewith the loop rotational position guide 424 along the loop engagedposition 520B. In some embodiments, the loop capture arm 416 may guidethe blood component collection loop 520 into the bearings 417 and/orbearing surfaces of the loop rotational position guide 424 as the upperhousing 404B and the blood component collection loop 520 rotate into theloop engaged position 520B. Further details regarding the loading of theblood component collection loop 520 are described in conjunction withFIGS. 6A-7B.

FIGS. 4D-4F show various schematic section views taken through thecenter of the centrifuge assembly 400 (e.g., bisecting the centrifugeassembly 400 through the centrifuge rotation axis 430, etc.). Asdescribed above, the centrifuge assembly 400 may include a lower housing404A that is pivotally attached to an upper housing 404B by asplit-housing pivot axis 406, or hinge. The upper housing 404B may beattached to an upper housing adapter 440 that is rotationallyinterconnected to the upper housing bushing block 442 attached to thepull ring 412. In one embodiment, a bearing 417, bushing, or bearingsurface may be disposed between the upper housing adapter 440 and theupper housing bushing block 442 allowing the upper housing 404B torotate along centrifuge rotation axis 430 from a locked position into anunlocked position, and vice versa. The pull ring 412 may be rotationallyfixed about centrifuge rotation axis 430 relative to the lower housing404A. In some embodiments, the upper housing adapter 440 and the upperhousing 404B may be formed from an integral structure.

The filler 460 may be fixedly attached to a filler mandrel 434 that isconfigured to rotate relative to the upper housing 404B about centrifugerotation axis 430. In one embodiment, the filler mandrel 434 may beformed from a portion of the filler 460. In any event, one or moremandrel support bearings 444 may be disposed between the filler mandrel434 and the upper housing adapter 440 allowing the filler 460 to rotateinside the centrifuge split-housing 404 and centrifuge assembly 400about the centrifuge rotation axis 430. In some embodiments, the fillermandrel 434 may be retained in an operative position via at least oneretaining nut 438. The filler 460 and filler mandrel 434 may spintogether relative to the centrifuge split-housing 404

FIG. 4D shows a schematic section view of the centrifuge assembly 400 ina closed state, e.g., prior to loading the blood component collectionloop 520, in accordance with embodiments of the present disclosure. Uponunlocking the upper housing 404B relative to the lower housing 404A, anoperator may pull on the pull ring 412 to pivot the entire upper housing404B and filler 460 about the split-housing pivot axis 406. In oneembodiment, the upper housing 404B and the filler 460 may be partiallyopened by pivoting the components about the split-housing pivot axis 406in an opening direction 446 as shown in FIG. 4E. As illustrated in FIG.4E, where the centrifuge assembly 400 is shown in a partially openedstate, the upper housing 404B and filler 460 are rotated out of axisfrom the lower housing rotation axis 430A. In this position, the filler460 may be allowed to rotate about the filler rotation axis 430B. Whenthe lower housing 404A and upper housing 404B are in a closed state, thelower housing rotation axis 430A and the filler rotation axis 430B align(coincidentally, or substantially coincidentally) to form the centrifugerotation axis 430.

Continuing to rotate the upper housing 404B and the filler 460 about theY-axis of the split-housing pivot axis 406 in the opening direction 446(e.g., by continuing to pull the pull ring 412) may cause the upperhousing 404B and the filler 460 to pivot substantially 180 degrees fromthe closed position shown in FIG. 4D. As shown in FIG. 4F, thecentrifuge assembly 400 is in an open, or loading, state. In thisposition, the upper housing 404B and the filler 460 may be pivotedoutside of the interior space of the apheresis system 200. For example,at least a portion of the upper housing 404B and/or the filler 460 maybe positioned through an open space of the opened access panel 224. Inthis position, a loading access area 450 may be provided to the loopconnection area 454 of the filler 460. As can be appreciated, orientingthe upper housing 404B in the open position provides easy access to theinterior of the upper housing 404B and the filler 460. Among otherthings, this arrangement may provide ample clearance for an operator toattach the blood component collection loop 520 to the filler 460 at theloop connection area 454.

Referring to FIG. 4G, a perspective view of a filler 460 for thecentrifuge assembly 400 is shown in accordance with embodiments of thepresent disclosure. In some embodiments, the filler 460 may be made froma lightweight material such as plastic, carbon fiber, aluminum, etc. Inone embodiment, the filler 460 may be three-dimensionally (3D) printedvia a 3D printing machine. For instance, the filler 460 may be producedvia an additive manufacturing technique or system such as fuseddeposition modeling (FDM), selective laser sintering (SLS),stereolithography (SLA), and/or other additive manufacturing machines.Among other things, these additive rapid prototyping manufacturingtechniques can allow for more complex geometries of the filler 460 thatmay not be possible through the use of conventional machining ormanufacturing processes. In some embodiments, the material of the filler460 may be selected based on a desired mass of the filler 460, thedesired physical strength of the manufactured filler 460, and/orsuitable material for use in manufacturing.

The filler 460 may include a loop connection area 454 disposedsubstantially at the center of the filler 460. The loop connection area454 may include one or more keying, or positive location, features for aportion of the blood component collection loop 520 to engage. As shownin FIG. 4G, the loop connection area 454 includes a first positivelocation feature 478 disposed along a portion of the center axis of thefiller 460. The first positive location feature 478 may be a keyway,groove, slot, or other feature for engaging with a mating featuredisposed on the blood component collection loop 520. In someembodiments, the filler 460 may include a second positive locationfeature 480 in the loop connection area 454. The location features 478,480 may prevent rotation of the blood component collection loop 520 atthe loop connection area 454 and/or prevent the blood componentcollection loop 520 from disengaging from the loop connection area 454of the filler 460.

In some embodiments, the filler 460 may include a collection insertchannel 466 configured to receive, and at least partially contain, ablood component collection bladder of the blood component collection setand, more specifically, the blood component collection loop 520. Thecollection insert channel 466 may be configured as a groove, slot,extending outwardly, in a substantially spiral fashion, from a center ofthe filler 460. In some embodiments, the collection insert channel 466may follow a substantially spiral shaped path that may include a firstspiral path portion extending outwardly from the center of the filler460 to a substantially constant radius (e.g., about the center of thefiller 460) along a length of the collection insert channel 466periphery. In any event, the path may be referred to herein as a spiralpath or a substantially spiral path. The collection insert channel 466may start at a channel entrance 468 adjacent to the center of the fillerbody 464 and terminate at a channel end 472 adjacent at a point furthestfrom the center of the filler body 464. As shown in FIGS. 4G-4I, thecollection insert channel 466 may extend along a substantially spiralpath 490 running from a point adjacent to the filler rotation axis 430Bto the channel end 472. The substantially spiral path 490 may include achannel path jog 476 at a point near, or adjacent to, the channel end472. This channel path jog 476 may extend the distance of the collectioninsert channel 466 from the center of the filler body 464 therebyincreasing the centripetal and centrifugal forces at the channel end 472of the collection insert channel 466. In one embodiment, this channelpath jog 476 may correspond to a critical inlet and exit port at aradial maximum within a blood component collection bladder 536 that isinserted or disposed, at least partially, within the collection insertchannel 466 of the filler 460. In some embodiments, the filler 460 mayinclude one or more filler balance protrusions 482 disposed on, in, orabout a portion of the filler body 464. These filler balance protrusions482 may provide an axially balanced (e.g., about the filler rotationaxis 430B) filler 460, especially when the collection insert channel 466includes a blood component collection bladder and fluid (e.g., blood,blood components, etc.).

FIG. 4I is a schematic plan view of a substantially spiral-shapedreceiving channel, or collection insert channel 466, for a filler 460 inaccordance with embodiments of the present disclosure. The schematicplan view shows a first distance, R1, of the collection insert channel466 from a center of the filler body 464 (e.g., adjacent to the fillerrotation axis 430B, etc.) at a first point along the substantiallyspiral path 490 and a second distance, R2, of the collection insertchannel 466 from the center of the filler body 464 past a point adjacentto the channel path jog 476. As illustrated in FIG. 4I, the seconddistance, R2, is further from the center of the filler body 464 than thefirst distance, R1. This increase in distance may provide highercentripetal and centrifugal forces in the channel at a point near, orat, the channel end 472 than at any other point along the substantiallyspiral path 490. In some embodiments, the end of the blood collectionbladder may substantially coincide with the channel end 472, providingthe greatest blood separation forces at the end of the bladder.

FIGS. 4J-4L show various elevation section of the filler 460 and, morespecifically of, the collection insert channel 466 and filler insertchamber 492 disposed inside the filler body 464. In some embodiments,the collection insert channel 466 may include a cross-section, or shape,that substantially follows the substantially spiral path 490 in thefiller body 464. The collection insert channel 466 may include an insertgroove configured to receive a substantially flat, or unfilled, bloodcomponent collection bladder. The blood component collection bladder maybe inserted into the collection insert channel 466 and a filler insertchamber 492 formed in the filler body 464 along the substantially spiralpath 490. The filler insert chamber 492 may be defined by one or moresidewalls 494, 496 forming a cavity that follows the substantiallyspiral path 490. As shown in FIG. 4K, the filler insert chamber 492includes an inner chamber wall 494 separated a distance from at leastone outer chamber wall 496. The filler insert chamber 492 may be formedin the filler 460 by 3D printing the filler 460 and/or by some othermetal or plastic forming operation, or operations (e.g., casting,molding, forming, etc.). In some embodiments, the filler insert chamber492 may include one or more insert guide features 498. These insertguide features 498 may be configured to guide, locate, and/or seat ablood component collection bladder inside the filler insert chamber 492of the filler 460. Although shown as a chamfered, or lead-in, feature ofthe filler insert chamber 492, the insert guide feature 498 may includeone or more radius, chamfer, slope, taper, draft angle, receptacle,groove, and/or other shaped material configured to direct and/or orienta portion of an inserted blood component collection bladder.

FIG. 4L shows different states of fluid collection bladders (e.g., bloodcomponent collection bladders, etc.) disposed inside the collectioninsert channel 466 and the filler insert chamber 492 of the filler 460.As described above, a blood component collection bladder may be insertedinto the collection insert channel 466 in a substantially flat, orunfilled, state, S1. In the substantially flat state, S1, the bloodcomponent collection bladder may be sized to enter the upper opening ofthe collection insert channel 466 and be maintained in a pre-fillcondition inside the filler insert chamber 492. When the filler 460begins to spin and separate blood components from blood provided by adonor 102, the blood component collection bladder may expand from thesubstantially flat first state, S1, to an expanded, or filled, state,S2. In some embodiments, the blood component collection bladder mayexpand with blood and/or blood components until the walls of the bloodcomponent collection bladder contact the walls 494, 496 of the fillerinsert chamber 492. In one embodiment, the shape of the filler insertchamber 492 may be designed to optimize the amount of fluid (e.g.,maximize the volume of fluid while minimizing the amount of material forthe filler 460) capable of being collected and/or separated in thefiller insert chamber 492.

FIG. 5A shows a schematic view of a blood component collection set 500in accordance with embodiments of the present disclosure. The bloodcomponent collection set 500 may include the tubing (e.g., one or moreof the donor feed tubing 104, cassette inlet tubing 108A, loop inlettubing 108B, anticoagulant tubing 110, loop exit tubing 112, salinetubing 116, plasma tubing 120, etc.), the connectors (e.g., one or moreof the tubing connector 106, saline and plasma tubing y-connector 280,tubing fittings 504, tubing fitting 508, bag spike fitting 512, etc.),soft cassette 340, and the blood component collection loop 520.

The tubing may include any tubing having a central lumen configured toconvey fluid therethrough. The tubing may be made from polyvinylchloride (PVC), plasticized-PVC, polyethylene, ethylene with vinylacetate (EVA), rubber, polymers, copolymers, and/or combinationsthereof. The connectors may be configured to fluidly interconnect withthe tubing (e.g., at one or more ends of the tubing, etc.). Theconnectors may insert into the central lumen of the tubing and/or attachto an outside of the tubing. In some embodiments, the connectors may beconfigured with various fittings (e.g., Luer fitting, twist-to-connect,and/or other small-bore couplings, etc.) to provide universal and/orreliable interconnections to one or more other fittings, connectors,tubing, needles, and/or medical accessory. In one embodiment, the bagspike fitting 512 may be configured to insert into a receiving bag(e.g., saline bag 118, etc.).

The blood component collection loop 520 may comprise a flexible loop 524disposed between a system static loop connector 528 and a filler loopconnector 532. The flexible loop 524 may be configured as a hollowflexible tube configured to receive and/or contain at least a portion ofthe loop inlet tubing 108B and the loop exit tubing 112. In someembodiments, the flexible loop 524 may be made from a thermoplasticelastomer having enhanced flexibility for transmitting twist from oneend of the flexible loop 524 to the other. These types of elastomers mayprovide the flexibility of rubber while maintaining the strength andtorque characteristics of plastics. Examples of the thermoplasticelastomer may include, but are in no way limited to, copolyester,DuPont™ Hytrel® thermoplastic elastomers, Eastman Neostar™ elastomers,Celanese Riteflex® elastomers, TOYOBO PELPRENE®, and/or other brandelastomers offering high flexibility and strength characteristics.

In some embodiments, the blood component collection loop 520 may includea blood component collection bladder 536 having a bladder loop end 540Aand a bladder free end 540B. The blood component collection bladder 536may include a first collection flow chamber 544 connected to theflexible loop 524 at the filler loop connector 532. In particular, fluidmay flow between the loop inlet tubing 108B and the first collectionflow chamber 544 via the flexible loop 524 and the connectors 528, 532,and/or vice versa. Fluid flowing in a direction from the bladder loopend 540A to the bladder free end 540B along the first collection flowchamber 544 may reach a flow chamber transition 548 and enter the secondcollection flow chamber 552. In one embodiment, the second collectionflow chamber 552 is interconnected to the flexible loop 524 at thefiller loop connector 532. In particular, fluid may flow between theloop exit tubing 112 and the second collection flow chamber 552 via theflexible loop 524 and the connectors 528, 532, and/or vice versa.

Details of the blood component collection loop 520 are illustrated inconjunction with the elevation view of FIG. 5B. The blood componentcollection loop 520 may include a flexible loop 524 configured as a tubeincluding a first pathway for the loop inlet tubing 108B and a secondpathway for the loop exit tubing 112. In some embodiments, the loopinlet tubing 108B may pass through the flexible loop 524 andinterconnect with the first collection flow chamber 544 at the bladderloop end 540A via the filler loop connector 532. Additionally oralternatively, the loop exit tubing 112 may pass through the flexibleloop 524 and interconnect with the second collection flow chamber 552 atthe bladder loop end 540A via the filler loop connector 532. The firstpathway is separate from the second pathway. This configuration allowsblood to enter the flexible loop 524 and the blood component collectionbladder 536 via the first collection flow chamber 544 and separate intoone or more blood components, which can then be conveyed along thesecond collection flow chamber 552 to the loop exit tubing 112 in theflexible loop 524.

The first collection flow chamber 544 may be separated from the secondcollection flow chamber 552 via a flow chamber separator 542. The flowchamber separator 542 may be a heat sealed portion of the bloodcomponent collection bladder 536. For example, the blood componentcollection bladder 536 may be made from layers of material overlappingone another along a length of the blood component collection bladder536. The layers of material may be shaped (e.g., cut or otherwiseshaped, etc.) and heat sealed along one or more edges forming a fluidcontainer. The flow chamber separator 542 may be formed in the fluidcontainer by heat sealing one layer of material to the other layer ofmaterial along a path as substantially illustrated. The flow chamberseparator 542 does not extend the complete length of the blood componentcollection bladder 536 providing a flow chamber transition 548 for fluid(e.g., blood, blood components, etc.) to pass from the first collectionflow chamber 544 to the second collection flow chamber 552, and/or viceversa. In one embodiment, fluid (e.g., blood and/or blood components,etc.) in the blood component collection bladder 536 contained in thefiller insert chamber 492 of the filler 460 may travel in a directiontoward the bladder free end 540B along the first collection flow chamber544 around an end of the flow chamber separator 542 (e.g., followingblood component movement direction 546) and into the second collectionflow chamber 552. In this example, blood components (e.g., plasma, etc.)may be forced back along the substantially spiral path 490 toward thecenter of the filler body 464 along the second collection flow chamber552 and through the loop exit tubing 112 (e.g., to a plasma collectionbottle 122).

The blood component collection bladder 536 may be made from polyvinylchloride (PVC), plasticized-PVC, polyethylene, ethylene with vinylacetate (EVA), thermoplastics, thermoplastic elastomer, polymers,copolymers, and/or combinations thereof. In some embodiments, the bloodcomponent collection bladder 536 may be formed, heat sealed frommultiple layers of material, formed from a single layer of materialfolded onto itself, and/or combinations thereof.

In some embodiments, the blood component collection loop 520 may includea number of positive location, or key, features 530A, 530B configured topositively locate portions of the blood component collection loop 520relative to the apheresis system 200 and/or the filler 460. For example,the blood component collection loop 520 includes a first connectorlocation feature 530A on the system static loop connector 528 and asecond connector location feature 530B on the filler loop connector 532.The features 530A, 530B may be configured as a key, a tab, and/or otherprotrusion of material extending from the connector 528, 532. In someembodiments, the second connector location feature 530B may includefeatures that interconnect, or mate, with the first positive locationfeature 478 and/or the second positive location feature 480 of the loopconnection area 454 in the filler 460. Similar, if not identical,positive location features may be associated with, or included in, thefixed loop connection 402 of the apheresis system 200.

FIGS. 5C and 5D show cross-sections of the blood component collectionbladder 536 of the blood component collection loop 520 in accordancewith embodiments of the present disclosure. For instance, thecross-sections show the first collection flow chamber 544 separate fromthe second collection flow chamber 552 along a length of the bloodcomponent collection bladder 536. In some embodiments, the separationmay be provided by a flow chamber separator 542 disposed between thefirst collection flow chamber 544 and the second collection flow chamber552. The flow chamber separator 542 may correspond to a sealed region ofthe blood component collection bladder 536. The flow chamber separator542 may be formed as a heat-sealed region of material, for instance,joining a bladder first side material 536A to a bladder second sidematerial 536B. In some cases, the bladder first side material 536A andthe bladder second side material 536B may be a single piece of materialfolded at an edge (e.g., adjacent to one of the upper bladder seal 554Aarea or the lower bladder seal 554B area).

The cross-section shown in FIG. 5D may correspond to a blood componentcollection bladder 536 prior to sealing, and the cross-section shown inFIG. 5C may correspond to the blood component collection bladder 536after the upper bladder seal 554A, lower bladder seal 554B, and/or theflow chamber separator 542 are formed or sealed (e.g., welding thebladder first side material 536A to the bladder second side material536B, etc.). Once formed, the width of the bladder, WB, may correspondto the width of the first collection flow chamber 544 and/or the secondcollection flow chamber 552 in an unexpanded state, S1 (see, e.g., FIG.4L). During operation, as fluid fills at least a portion of the bloodcomponent collection bladder 536, the width of the bladder, WB, mayincrease in dimension from the dimension shown in FIG. 5C. For instance,the width of the bladder, WB, may increase substantially to the size ofthe filler insert chamber 492 of the filler 460. In some embodiments,the welds (e.g., RF, ultrasonic, etc.) made while manufacturing theblood component collection bladder 536 may be supported in the filler460. In one embodiment, the top of the filler 460 supports the top twowelds and the bottom of the filler 460 supports a final weld.

FIGS. 5E-5H show various perspective views of the blood componentcollection loop 520 in a flexed state (e.g., FIGS. 5E-5F) as well asviews of the flexed blood component collection bladder 536 of the bloodcomponent collection loop 520 being inserting into a filler 460 (e.g.,FIGS. 5G-5H). The various components of the blood component collectionloop 520 may be flexible and/or capable of being formed or shaped by theapplication of force. In some embodiments, this flexibility may beelastic such that forming the various parts of the blood componentcollection loop 520 does not permanently deform the components. FIG. 5Eshows the blood component collection loop 520 in a flexed state inaccordance with embodiments of the present disclosure. For example, theflexible loop 524 is shown elastically bent along its length and theblood component collection bladder 536 is shown following a number ofbends or curves along its length. The flexible loop 524 may still conveyfluids provided via the loop inlet tubing 108B to the first collectionflow chamber 544 of the blood component collection bladder 536, and viceversa, while the components are in a flexed state. Additionally oralternatively, the flexible loop 524 may convey fluids from the secondcollection flow chamber 552 of the blood component collection bladder536 to the loop exit tubing 112, and vice versa, while the componentsare in the flexed state.

In some embodiments, the blood component collection loop 520 may bepre-formed, as shown in the perspective view of FIG. 5F, to fit insidethe collection insert channel 466 of a filler 460. This pre-forming mayinclude twisting the blood component collection bladder 536 of the bloodcomponent collection loop 520 to match the substantially spiral path 490of the collection insert channel 466. Once pre-formed, the features ofthe blood component collection loop 520 may be aligned with one or morefeatures of the filler 460, as shown in FIG. 5G. In one embodiment, thefiller loop connector 532 of the blood component collection loop 520 maybe aligned with the loop connection area 454 of the filler 460 such thatthe second connector location feature 530B is aligned to engage with thefirst positive location feature 478. Additionally or alternatively, theblood component collection bladder 536 may be shaped, or formed (e.g.,by hand, etc.), to match the substantially spiral path 490 of thecollection insert channel 466 in the filler 460. In some cases, thisshaping or forming may include aligning the bladder free end 540B of theblood component collection bladder 536 with the channel end 472 of thecollection insert channel 466 in the filler 460. When the components aregenerally aligned with one another, the blood component collection loop520 may be moved in a direction toward the collection insert channel 466and the loop connection area 454 (as shown in FIG. 5G).

In some embodiments, when the filler loop connector 532 is moved towardand into the loop connection area 454 of the filler 460, the firstpositive location feature 478 may interconnect and/or retain the secondconnector location feature 530B of the filler loop connector 532 of theblood component collection loop 520. This interconnection may preventthe filler loop connector 532 from rotating relative to the filler 460.In some cases, the interconnection may maintain the filler loopconnector 532 of the blood component collection loop 520 inside the loopconnection area 454 of the filler 460. FIG. 5H shows a perspective viewof the blood component collection loop 520 loaded in the filler 460 inaccordance with embodiments of the present disclosure.

FIGS. 6A-6C show schematic section views of a centrifuge assembly 400 invarious loop-loading states in accordance with embodiments of thepresent disclosure. The centrifuge assembly 400 shown in FIGS. 6A-6C maycorrespond to the centrifuge assembly 400 described above and especiallyin conjunction with FIGS. 4D-4F. In particular, FIG. 6A shows aschematic section view of a first loop-loading state, FIG. 6B shows aschematic section view of a second loop-loading state, and FIG. 6C showsa schematic section view of a second loop-loading state for thecentrifuge assembly 400.

In FIG. 6A, the centrifuge assembly 400 is shown in an open,loop-loading, position where the upper housing 404B has been pivoted 180degrees from a closed, or operational, position. This open position maycorrespond to the position of the centrifuge assembly 400 shown in FIG.4F. However, in FIG. 6A, a blood component collection loop 520 has beeninserted into the filler 460 and the filler loop connector 532 isinterconnected to the loop connection area 454 of the filler body 464.The other end of the blood component collection loop 520 is connected tothe fixed loop connection 402 via the system static loop connector 528.In this first loop-loading state, the flexible loop 524 is fixed fromrotating at the fixed loop connection 402 but rotates, in unison, withthe filler 460 at the loop connection area 454.

In FIG. 6B, the centrifuge assembly 400 is shown in a partially closedposition where the upper housing 404B is being moved from the openposition to a closed, or operational, position. As the upper housing404B pivots, the flexible loop 524 may move to a resting positionrelative to the centrifuge assembly 400. Although the flexible loop 524is rotationally fixed at the fixed loop connection 402, the filler 460may be free to rotate about the filler rotation axis 430B (e.g.,restricted only by the rotationally fixed flexible loop 524).

In FIG. 6C, the centrifuge assembly 400 is shown in a closed, oroperational, position where the upper housing 404B may be locked to thelower housing 404A (such that the lower housing 404A and the upperhousing 404B may rotate in unison about the centrifuge rotation axis430). In this position, the flexible loop 524 may pass from the loopconnection area 454 of the filler 460 through the loop access clearance436 of the centrifuge split-housing 404 to the fixed loop connection402. In some embodiments, the flexible loop 524 may be free to movewithin the loop access clearance 436 with or without contacting one ormore portions of the centrifuge split-housing 404. In this position, asthe centrifuge assembly 400 rotates about the centrifuge rotation axis430, the flexible loop 524 rotationally fixed at the fixed loopconnection 402 may twist along the length of the flexible loop 524thereby rotating the filler 460 inside the centrifuge assembly 400(e.g., along the centrifuge rotation axis 430). As provided above, therotation of the filler 460 relative to the centrifuge assembly 400 maybe at a 2:1 ratio. For instance, as the centrifuge assembly 400 rotatesone revolution, the rotationally fixed flexible loop 524 (e.g., fixed atthe fixed loop connection 402) twists at the loop connection area 454(e.g., trying to unravel from being twisted by the rotation of thecentrifuge assembly 400, etc.) thereby rotating the filler 460 in thesame rotational direction as the centrifuge assembly 400 but atsubstantially two revolutions. This rotation of the filler 460, by thetwisting of the flexible loop 524 along its length, requires no gearingbetween the centrifuge assembly 400 and the filler 460.

FIGS. 7A-7B show schematic plan views of the centrifuge assembly 400automatically loading a loop into an operational position (e.g., bloodseparation) for centrifuging. The centrifuge assembly 400 shown in FIGS.7A-7B may correspond to the centrifuge assembly 400 as previouslydiscussed and/or as described in conjunction with FIGS. 4A-4F and FIGS.6A-6C. Once the blood component collection loop 520 has been loaded intothe centrifuge assembly 400, as illustrated in FIG. 6C, the flexibleloop 524 may be automatically loaded into a loop engaged position 520Bas shown in FIGS. 7A-7B.

In one embodiment, when the upper housing 404B is locked to the lowerhousing 404A, the flexible loop 524 may run from the loop connectionarea 454 of the filler 460 to the fixed loop connection 402 of theapheresis system 200. Although the flexible loop 524 may be rotationallyfixed to the fixed loop connection 402 at the system static loopconnector 528, the flexible loop 524 passing through the loop accessclearance 436 in the centrifuge split-housing 404 may not initially beheld, or at least partially captured, by the loop rotational positionguide 424 and/or other features of the centrifuge assembly 400. Thisstate of the flexible loop 524 relative to the loop rotational positionguide 424, or loop arm, may correspond to an uncaptured loop state 700A.In other words, the flexible loop 524 may be oriented at some angle, a,relative to the loop rotational position guide 424, loop position stopplate 704, and/or one or more loop twist support bearings 708, orbearing sets. In some embodiments, the loop twist support bearing 708may correspond to the bearings 417 described in conjunction with FIGS.4B-4C. A loop containment area, or channel, may be formed by the loopposition stop plate 704, and/or one or more loop twist support bearings708 disposed along a length of the upper housing 404B. In someembodiments, this orientation may be engineered to allow access and/orease of loading during the loop-loading described in conjunction withFIGS. 6A-6C.

As the centrifuge assembly 400 is rotated in a loop and filler rotationdirection 712 about centrifuge rotation axis 430, the flexible loop 524may move from the uncaptured loop state 700A to the captured loop state700B shown in FIG. 7B. This rotation may be caused by an operatorrotating the centrifuge assembly 400 and/or the filler 460 in the loopand filler rotation direction 712 and/or by the rotor and motor assembly414 causing the centrifuge assembly 400 to rotate about the centrifugerotation axis 430. In some embodiments, as the flexible loop 524 rotatesin the loop and filler rotation direction 712, an outer portion of theflexible loop 524 may contact a loop position stop plate 704, or otherrotational stop surface, of the loop rotational position guide 424.

While the flexible loop 524 is held, or at least partially contained, inthe loop rotational position guide 424, a portion of the flexible loop524 may move within one or more of the loop twist support bearings 708.As described above, the flexible loop 524 may be rotationally fixed tothe fixed loop connection 402 via the first connector location feature530A of the system static loop connector 528 associated with the bloodcomponent collection loop 520. This rotationally fixed connectionprevents the flexible loop 524 from rotating relative to the apheresissystem 200 at the fixed loop connection 402. The other end of theflexible loop 524 may be interconnected at the loop connection area 454of the filler 460 where the end can move with the filler 460 and/orcentrifuge assembly 400. As the centrifuge assembly 400 continues torotate in the loop and filler rotation direction 712, the forces fromthe flexible loop 524 attempting to unravel, or keep from binding,rotate the filler 460 and the end of the flexible loop 524 attachedthereto.

In any event, once the fluid separation methods described herein arecompleted, the centrifuge assembly 400 may be stopped from rotating andthe centrifuge split-housing 404 can be opened to remove the disposableelements of the blood component collection set 500 from the centrifugeassembly 400. In some cases, the flexible loop 524 may be moved from thecaptured loop state 700B shown in FIG. 7B to the uncaptured loop state700A shown in FIG. 7A by rotating the centrifuge assembly 400 and/or thefiller 460 in a direction opposite the loop and filler rotationdirection 712.

A functional diagram of the apheresis system 200 may be as shown in FIG.8 in accordance with embodiments of the present disclosure. Thedescription herein shows the components previously described, in FIGS.1-7B, in a functional diagram to describe the operation of the system200 for extracting plasma or other blood components from the whole bloodof a donor 102 during an apheresis procedure or process.

The system 200 can include an anticoagulant (AC) pump 216. The AC pump216 pumps fluid in AC tubing 110 from the AC bag 114. The AC pump 216,the AC tubing 110, and/or the AC bag 114 may be as described previously.The AC tubing 110 may also include an AC air detection sensor (ADS) 804to detect air or fluid within the AC tubing 110. The AC ADS 804 may bethe same or similar in type and/or function to sensor 284 and/or sensor312, described previously. AC tubing 110 can intersect with and befluidly associated with the donor feed tubing 104 and the cassette inlettubing 108A at tubing connector 106. The tubing connector 106 can be anytype of connection between tubing 110, 104, and/or 108A, as describedpreviously.

The donor feed tubing 104 proceeds from the donor 102, where the donor102 may be stuck with a lumen needle or other device, allowing wholeblood to flow from the donor 102 into the apheresis system 200 andallowing blood components to flow back to the donor 102. Tubing 108A mayproceed to the soft cassette 340. Further, a donor air detection sensor312 can be placed on or in tubing 108A to detect the presence of fluidand/or air within tubing 108A.

As explained previously, the soft cassette 340 can include the firstcassette port 360A, which can function as, include, and/or besubstantially proximate to a “Y” connector or section, or branches, thatseparates the tubing 108A into the first bypass branch 358A and thefirst tubing section 368A (the “Y” section will be designated byreference character 360A). The two tubing sections 358 and 368 canreconnect at the second cassette port 360B, which can also function as,include, and/or be substantially proximate to a second “Y” connector orsection (the second “Y” section will be designated by referencecharacter 360B). Tubing 358 is bisected by the fluid sensor 316, whichseparates the tubing 358 into the first bypass branch 358A and thesecond bypass branch 358B. Likewise, tubing 368 is bisected by the dripchamber 354 that separates tubing 368 into a first tubing section 368Aand a second tubing section 368B.

The first tubing section 368A can include a first fluid control valve320A. The second tubing second 368B can likewise include a second fluidcontrol valve 320B. The first bypass branch 358A can similarly include adraw fluid control valve 320C. As such, the various sections of tubing368A, 358A, 358B, and 368B can be isolated by the valves 320A, 320B,and/or 320C based on the configuration of the system 200 and dependingon the operation of the system 200.

A drip chamber 354 may be disposed between the first tubing section 368Aand the second tubing section 368B. The drip chamber 354 can collect avolume of whole blood and/or high hematocrit blood (blood with a highpercentage of red blood cells) depending on the operation of the system200, as described hereinafter. The fluid sensor 316, as describedpreviously, may be disposed between the first bypass branch 358A and thesecond bypass branch 358B.

Loop inlet tubing 108B can connect to the second cassette port 360B andcan connect the soft cassette 340 to the flexible loop 524. The loopinlet tubing 108B may also include a sensor 808, disposed on or in thetubing 108B, placed with the tubing 108B before connecting with thesystem static loop connector 528 of the flexible loop 524. The pressuresensor (CPS) 808 may detect one or more of, but not limited to:pressure, presence of fluid or air, and/or possibly anothercharacteristic of the fluid in tube 108B. Further, a draw pump 208 cancause fluid to be pumped through tubing 108B either away from the softcassette 340 or to the soft cassette 340.

Two or more different tubes can be connected to the flexible loop 524through the system static loop connector 528 and provide fluid to, orreceive fluid from, the blood component collection bladder 536. A loopexit tubing 112 exits the system static loop connector 528 from flexibleloop 524. This loop exit tubing 112 can also include another line sensor812 disposed thereon or therein to detect fluid, air, cellularconcentration, color, and/or color change in the fluid coming from theflexible loop 524; the line sensor 812 can be the same or similar intype and/or function to sensors 804, 312, 320, 808, and/or 284previously described. A second CPS sensor 816 or fluid sensor may alsobe disposed in or on line 112. Sensor 816 may detect one or more of, butnot limited to: the presence or absence of fluid, pressure within tubing112, and/or other characteristic of the fluid in tubing 112. Similarly,sensor 816 can be the same or similar in type and/or function to sensors804, 312, 320, 808, 812 and/or 284 previously described.

Loop exit tubing 112 may then flow into a plasma air detection sensor284 before the saline and plasma tubing y-connector 280 separates thetubing 112 into saline tubing 116 and plasma tubing 120. The return pump212 may interact with the loop exit tubing 112 and can cause fluid orair to flow through tubing 112 from either the flexible loop 524 or froma saline bag 118 and/or a plasma collection bottle 122.

The saline bag 118 and associated tubing can be as previously describedand can provide saline through the system 200 back to the donor 102. Asaline flow control valve 288 can isolate the saline bag 118 from therest of the system 200. Further, a plasma collection bottle 122 canreceive plasma from the flexible loop 524 when processed or separatedfrom the whole blood. The plasma collection bottle 122 can beselectively isolated from the system by the plasma flow control valve286.

An embodiment of the electrical and control system 900 controlling thefunctions of the apheresis system 200 may be as shown in FIG. 9 inaccordance with embodiments of the present disclosure. The controlsystem 900 can include one or more nodes, which can include varioushardware, firmware, and/or software configured to control and/orcommunicate with the mechanical, electromechanical, and electricalcomponents of the apheresis system 200.

Each node may function to control a different part of the apheresissystem 200. For example, the control system 900 can include a cassettenode 904 and a centrifuge node 908, which may control or communicatewith the components of the blood component collection set 500 (and theassociated hardware or mechanical components interfacing with the softcassette assembly 300) and the centrifuge assembly 400 (and theassociated hardware or mechanical components associated therewith),respectively. The cassette node 904 and centrifuge node 908 may be incommunication either wirelessly or through some other electrical or dataconnection. In some configurations, the separate nodes 904, 908 may betwo portions of a single node 902. As such, each node 904, 908 may havethe same physical hardware operating to control different functions. Anexample of the cassette node 904 may be as described in conjunction withFIG. 10 ; a centrifuge node 908 may be as described in conjunction withFIG. 11 .

Each of the nodes 904, 908 may be in communication with one or moresensors 916, 920, and/or 924. There may be more or fewer sensors thanthose shown in FIG. 9 , as represented by ellipsis 928. Each node 904,908 can communicate directly to each sensor 916-924 or may communicatewith the several sensors 916-924 via a bus 912. The bus 912 maycommunicate by any type of communication protocol, such as universalserial bus (USB), a universal asynchronous receive/transmit (UART), orother types of bus systems or parallel communication connections. Thus,the bus 912 may be optional, but is shown as a possible communicationplatform to communicate with the various sensors 916-924. The sensors916-924 can be any type of sensor that can communicate information aboutlight, fluid, the presence of air, color, pressure, etc., as describedherein. Some of the sensors 916-924 can include sensors 312, 316, 804,808, 812, 816, and/or 284. The function of these sensors 912-924 may beas described hereinafter.

The nodes 904, 908 may also communicate with one or more pump drives,pump motors, etc. 936, 940, 944, simply referred to as “pumps.” Theremay be more or fewer pumps than are shown in FIG. 9 , as represented byellipsis 948. The nodes 904, 908 can communicate with the pumps 936-944through direct wired or wireless communication or through a bus 932. Thebus 932 can be a control area network (CAN) bus, USB, or other type ofbus architecture to communicate with the pumps 936-944. The pumps936-944 can include pumps 216, 208, and/or 212, as previously described.The function of the pumps 936-944 may be described as herein.

An embodiment of the cassette node 904 may be as shown in FIG. 10 inaccordance with embodiments of the present disclosure. The cassette node904 can include one or more of a controller 1004, a memory 1008, a valvecontroller 1020, and/or communication interfaces for a CAN bus 1016, aUART 1012, or other types of buses. The cassette node 904 can includeother hardware, firmware, and/or software that are not shown forclarity.

The controller 1004 can be any type of microcontroller, microprocessor,Field Programmable Gate Array (FPGA), Application Specific IntegratedCircuit (ASIC), etc. An example controller 1004 may be theNK10DN512VOK10 microcontroller, made and sold by N9P USA, Incorporated,which is a microcontroller unit with a 32-bit architecture. Other typesof controllers are possible. The controller 1004 can control other typesof devices or direct the functions of other types of devices, such asvalves 320A, 320B, 320C, 286, 288, pumps 936-944, etc. Further, thecontroller 1004 can communicate with various sensors 916-924 or otherdevices to receive or send information regarding the function of theapheresis system 200.

Other examples of the processors or microcontrollers 1004, as describedherein, may include, but are not limited to, at least one of Qualcomm®Snapdragon® 800 and 801, Qualcomm® Snapdragon® 610 and 615 with 4G LTEIntegration and 64-bit computing, Apple® A7 processor with 64-bitarchitecture, Apple® M7 motion coprocessors, Samsung® Exynos® series,the Intel® Core™ family of processors, the Intel® Xeon® family ofprocessors, the Intel® Atom™ family of processors, the Intel Itanium®family of processors, Intel® Core® i5-4670K and i7-4770K 22 nm Haswell,Intel® Core® i5-3570K 22 nm Ivy Bridge, the AMD® FX™ family ofprocessors, AMD® FX-4300, FX-6300, and FX-8350 32 nm Vishera, AMD®Kaveri processors, ARM® Cortex™-M processors, ARM® Cortex-A andARM926EJ-S™ processors, other industry-equivalent processors, and mayperform computational functions using any known or future-developedstandard, instruction set, libraries, and/or architecture.

The memory 1008 can be any type of memory including random access memory(RAM), read only memory (ROM), electrically erasable programmable ROM(EEPROM), a portable compact disc read-only memory (CD-ROM), an opticalstorage device, a magnetic storage device, any suitable combination ofthe foregoing, or other type of storage or memory device that stores andprovides instructions to program and control the controller 1004. Thememory 1008 may provide all types of software or firmware that programsthe functions of the controller 1004, as described hereinafter.

The controller 1004 can communicate with one or more valve controllers1020. Each valve 320A, 320B, 320C, 286, 288, as described herein, may becontrolled by a valve controller 1020 and may be associated with acomponent of the system 200, as described herein. The valve controller1020 can provide the electrical signal, operational directive, or powerto close or open any one of the valves described herein, for example,the saline and plasma valve housing 276, the plasma flow control valve286, the saline flow control valve 288, the first fluid control valve320A, the first fluid control valve 320A, and/or the draw fluid controlvalve 320C, etc.

The controller 1004 can also be connected to a bus 912, 932 (e.g., UARTbus, CAN bus), or other busses through transceivers 1012, 1016 providedoutside of the controller 1004 or integral to the controller 1004. TheUART transceiver 1012 may communicate with one or more of the sensors916-924 or other devices. Likewise, the CAN bus transceiver 1016 cancommunicate with one or more of the pump controllers 936-944 or otherdevices. UART transceivers 1012 and busses and CAN bus transceivers 1016and busses are well known in the art and need not be explained furtherherein.

An embodiment of the centrifuge node 908 may be as shown in FIG. 11 , inaccordance with embodiments of the present disclosure. The centrifugenode 908, can include the same or similar types of components as thecassette node 904. For example, the centrifuge node 908 can include acontroller 1104, a UART transceiver 1112, etc. Similar to the controller1004, the controller 1104 can be any type of processor ormicrocontroller, for example the NK10DN512VOK10 microcontroller unitwith 32-bit architecture from N9P USA, Incorporated, as mentionedpreviously, or other controllers, processors, etc., for example, thedevices mentioned previously.

The controller 1104 can communicate with the sensors 916-924 directly,through the UART transceiver 1112, or through other busses or systems.The controller 1104 can also communicate with a brake controller 1124that can brake or slow and stop the centrifuge 400. Likewise, acontroller 1104 can communicate with a motor transceiver 1116 thatcommunicates with a motor power system or a motor controller thatfunctions to spin up or rotate the centrifuge 400 or control the speedsetting or other function of the centrifuge 400.

In some configurations, the controller 1104 can also communicate with acuff controller 1122 that can change or set the pressure of a pressurecuff on a donor's arm during the apheresis process. Further, thecontroller 1104 can communicate with and/or control a strobe 1112, whichcan be any light that flashes at a periodicity in synchronicity with therate of spin of the motor, such that an operator of the apheresis system200 can see the operation of the filler 460, as described previously.Thus, the controller 1104 can communicate with the strobe 1112 to changethe frequency of the flashing of the strobe light 1112, the intensity ofthe strobe light 1112, etc.

Embodiments of a method 1200 used to complete blood component (e.g.,plasma) apheresis, with the system 200, may be as shown with FIG. 12 ,in accordance with embodiments of the present disclosure. The method1200 may be described in conjunction with FIGS. 17A-17T. As such, themethod 1200 will be described in relation or with reference to thosefigures. A general order for the steps of the method 1200 is shown inFIG. 12 . Generally, the method 1200 starts with a start operation 1204and ends with operation 1220. The method 1200 can include more or fewersteps or can arrange the order of the steps differently than those shownin FIG. 12 . The method 1200 can be, at least partially, executed as aset of computer-executable instructions executed by a computer system,processor, cassette microcontroller 1004, centrifuge microcontroller1104, and/or another device and encoded or stored on a computer readablemedium. In other configurations, the method 1200 may be executed, atleast partially, by a series of components, circuits, gates, etc.created in a hardware device, such as a System on Chip (SOC),Application Specific Integrated Circuit (ASIC), and/or a FieldProgrammable Gate Array (FPGA). Hereinafter, the method 1200 shall beexplained with reference to the systems, devices, valves, pumps,sensors, components, circuits, modules, software, data structures,signaling processes, models, environments, apheresis systems, etc.described in conjunction with FIGS. 1-11 .

The method 1200 can generally be separated into three phases, where eachphase includes a series of steps or processes. Each of the three phasesis described in FIG. 12 and with reference to FIGS. 13-16 , whichdescribe the steps or processes. The method 1200 can include a preparingthe system phase, in step 1208. In this phase 1208, the operator canprepare the system 200 for apheresis, which might include steps to placethe needle in the donor 102, conduct other operations to prepare forblood draw, insert the blood component collection set 500 into thesystem, etc. An example of the steps that may be included in thepreparing the system phase 1208 may be as described in conjunction withFIG. 13 .

The method 1200 may then enter a draw plasma phase, in step 1212. Thedraw plasma phase 1212 may be as described in conjunction with FIG. 14 .The draw plasma phase 1212 can include the drawing of the blood,centrifuging of blood to extract plasma (and/or other blood components),pushing the high hematocrit blood (e.g., red blood cells), and/or otherblood components, back to the donor 102 in various return cycles (untila full sample of plasma and/or other blood component is collected), etc.The start of the return cycles may be triggered based on the presence,at some predetermined position in the apheresis system, of one or moreblood components, e.g., platelets, red blood cells, etc.

The final phase of the method 1200 can be an unload disposable phase, instep 1216. The unload disposable phase 1216 may be described inconjunction with FIG. 15 . The unload disposable phase 1216 can includethe completion of the apheresis process, the removing of the needle fromthe donor 102, unloading the blood component collection set 500, andcompleting the procedure. Each of the three phases 1208-1216, and thesteps or process associated therewith, will now be describedhereinafter.

A method for prepping the apheresis system 200, as described in phase1208, may be as shown in FIG. 13 , in accordance with embodiments of thepresent disclosure. A general order for the steps of the method 1300 isshown in FIG. 13 . Generally, the method 1300 starts with a startoperation 1304 and ends with operation 1328. The method 1300 can includemore or fewer steps or can arrange the order of the steps differentlythan those shown in FIG. 13 . The method 1300 can be, at leastpartially, executed as a set of computer-executable instructionsexecuted by a computer system, processor, cassette microcontroller 1004,centrifuge microcontroller 1104, and/or other devices and encoded orstored on a computer readable medium. In other configurations, themethod 1300 may be executed, at least partially, by a series ofcomponents, circuits, gates, etc. created in a hardware device, such asa SOC, ASIC, and/or a FPGA. Hereinafter, the method 1300 shall beexplained with reference to the systems, devices, valves, pumps,sensors, components, circuits, modules, software, data structures,signaling processes, models, environments, apheresis systems, methods,etc. described in conjunction with FIGS. 1-12 .

A user, or operator, may load the blood component collection set 500, instep 1308. In this step 1308, the user can load the blood componentcollection set 500 into the system 200, including inserting the flexibleloop 524 into the loop containment bracket 426 and the blood componentcollection bladder 536 into the filler 460 (which may both be asdescribed in FIG. 16 ). Further, the soft cassette 340 may be mounted inthe soft cassette assembly 300, as described in conjunction with FIGS.1, 2A, 2B, 3A, and/or 3B. The loop inlet tubing 108B can be insertedinto the lead tubing guide 244 and/or end tubing guide 252 to the drawpump 208 to cause fluid movement in the loop inlet tubing 108B and otherparts of the blood component collection set 500. Similarly, theanticoagulant tubing 110 can be placed into tubing guides, similar toguides 244, 252, to allow the AC pump 216 to move anticoagulant into theanticoagulant tubing 110 or other parts of the blood componentcollection set 500. The loop exit tubing 112 can be inserted intosimilar guides 244, 252 to allow the return pump 212 to move bloodcomponents (e.g., plasma) into the plasma collection bottle 122 or movesaline from the saline bag 118 into the loop exit tubing 112 or otherportions of the blood component collection set 500.

As shown in FIG. 2D, the saline and plasma tubing y-connector 280 can bemounted into a plasma and saline valve control system 228 to allow thevalves 286, 288 to control fluid flow from and/or to the plasmacollection bottle 122 and/or the saline bag 118. The AC bag 114 may bemounted onto an anticoagulant support 232A, the plasma collection bottle122 can be placed in the plasma collection cradle 232C, and the salinebag 118 can be mounted onto the saline support 232B, as described inFIGS. 1-2B. With the blood component collection set 500 mounted in theapheresis system 200, the apheresis system 200 may appear as shown inFIGS. 17A and 17B. The status of the various components of the apheresissystem 200, during this step, may be as shown below:

TABLE 1 Load Kit Status Load Kit Status Flow Spin Rate Open/ RateComponent Name (mL/min) Occlude? Closed? (RPM) Draw pump 208 0 No Returnpump 212 0 No Anticoagulant pump 216 0 Plasma flow control valve 286Open Saline flow control valve 288 Open First fluid control valve 320AOpen Second fluid control valve Open 320B Draw fluid control valve 320COpen Filler 460 0As shown in the above table and in subsequent tables, the draw pump 208and return pump 212 can occlude the loop inlet tubing 108B and theanticoagulant tubing 110, respectively. In this way, the draw pump 208and return pump 212 function as “valves” that selectively allow ordisallow fluid flow. A minus sign, “−”, in the “Flow Rate” columnrepresents that the pump is moving in a counterclockwise rotation. Theabbreviation “AF” means “Auto-flow” and represents that the pump isfunctioning at the flowrate of the blood coming from the donor 102. ThisAF flowrate prevents the apheresis system 200 from syphoning blood fromthe donor 102 or backing the flow of blood into the donor 102 and/or AFoptimizes draw and return flowrates while improving donor safety.

The saline bag 118 may be spiked, in step 1312. A user can remove anysafety coverings from a bag spike fitting 512, at the distal end of thesaline tubing 116, to puncture the saline bag 118, which contains thesaline. In other configurations, the saline tubing 116 may bemechanically attached to the saline bag 118 (e.g., by a Luer connector)and a frangible device or other removable barrier may be modified, by auser, to allow for the flow of saline from the saline bag 118. Thus,spiking the saline bag 118 allows saline to flow into the bloodcomponent collection set 500 to or through the saline flow control valve288. The status of the various components of the apheresis system 200,during this step, may be as shown below:

TABLE 2 Spike Saline Status Spike Saline Status Flow Spin Rate Open/Rate Component Name (mL/min) Occlude? Closed? (RPM) Draw pump 208 0 NoReturn pump 212 0 Yes Anticoagulant pump 216 0 Plasma flow control valve286 Closed Saline flow control valve 288 Closed First fluid controlvalve 320A Open Second fluid control valve Open 320B Draw fluid controlvalve 320C Open Filler 460 0

In step 1316, the saline 1712 is primed. Priming the saline 1712includes the cassette microcontroller 1004 directing the opening of thesaline flow control valve 288, as shown in FIG. 17D. The cassettemicrocontroller 1004 can receive instructions for a user interface orprogram to begin the apheresis process, which begins by priming thesaline 1712. Thus, the saline 1712 moves from the saline bag 118,through the saline flow control valve 288 to the plasma air detectionsensor 284. The cassette microcontroller 1004 directs thecounterclockwise rotation of the return pump 212 to cause the volumetricflow of saline 1712 from the saline bag 118 and through saline tubing116 and the saline and plasma tubing y-connector 280, mounted in theplasma and saline valve control system 228, to the plasma air detectionsensor 284. Upon the plasma air detection sensor 284 detecting eitherthe presence of liquid or the lack of air in the loop exit tubing 112, asignal is sent to the cassette microcontroller 1004. The cassettemicrocontroller 1004 may then direct the return pump 212 to stoprotations and direct the saline flow control valve 288 to close, whichprevents saline 1712 from further entering the loop exit tubing 112substantially beyond the plasma air detection sensor 284. At this pointin the process, the apheresis system may appears as shown in FIG. 17E.The status of the various components of the apheresis system 200, duringthis step, may be as shown below:

TABLE 3 Prime Saline Status Prime Saline Status Flow Spin Rate Open/Rate Component Name (mL/min) Occlude? Closed? (RPM) Draw pump 208 0 NoReturn pump 212 −10 Yes Anticoagulant pump 216 0 Plasma flow controlvalve 286 Closed Saline flow control valve 288 Open First fluid controlvalve 320A Open Second fluid control valve Open 320B Draw fluid controlvalve 320C Open Filler 460 0

It should be noted that the return pump 212 is described as moving inthe counterclockwise rotation. This direction of rotation is associatedwith the location of the return pump 212 in relation to the loop exittubing 112. If the return pump 212 is mounted with the loop exit tubing112 below the return pump 212, the return pump 212 would rotate in theclockwise direction to move the saline 1712 from the saline bag 118.Thus, throughout this description, the direction of pump rotation willbe described for the return pump 212, the draw pump 208, and/or the ACpump 216, but those directions of rotations may be different if thepumps 208, 212, 216 are mounted or placed differently. Further, othertypes of pumps may be used, which would change how the pumps operate tomove the various liquids or air in the system 200. One skilled in theart would understand how to make these modifications to accomplishsimilar results as described in the following processes and steps.

Further, the volumes moved and the rates of movement in the apheresissystem 200 are mentioned or described in the Tables included herein.However, these volumes and rates depend on the size of the tubing, thesize of the bags used, the desired volume of the collected bloodcomponent (e.g., 880 mL of plasma), and other considerations. State orcountry laws and other directives may govern the volumes and rates usedin the apheresis system 200 or those volumes moved and the rates ofmovement can be predetermined based on the direction of a medicalprofessional or based on the characteristics of the donor 102. As such,the volumes moved and the rates of movement are only exemplary, but oneskilled in the art would know which volumes moved and the rates ofmovement to establish for the following steps and processes.

Thereinafter, the anticoagulant (AC) 1702 may be spiked, in step 1320.Spiking the anticoagulant 1702 can be a similar process to spiking thesaline 1712. For example, a tubing fitting 508 can be attached to the ACbag 114 by a user. The user may then break a frangible, open a valve orother device, or modify some structure that will allow AC 1702 to flowinto the anticoagulant tubing 110. In other configurations, a needle maybe inserted into the AC bag 114 by the user. At this point in theprocess, the apheresis system 200 may appear as shown in FIG. 17E. Thecassette microcontroller 1004 may be signaled by the user, through auser interface or other user input device, that the AC bag 114 has beenconnected or spiked. The status of the various components of theapheresis system 200, during this step, may be as shown below:

TABLE 4 Spike Anticoagulant Status Spike Anticoagulant Status Flow SpinRate Oc- Open/ Rate Component Name (mL/min) clude? Closed? (RPM) Drawpump 208 0 No Return pump 212 0 Yes Anticoagulant pump 216 0 Plasma flowcontrol valve 286 Closed Saline flow control valve 288 Closed Firstfluid control valve 320A Open Second fluid control valve 320B Open Drawfluid control valve 320C Open Filler 460 0

In response to the signal from the user, the cassette microcontroller1004 may then prime the AC 1702, in step 1324. To prime the AC 1702, thecassette microcontroller 1004 can direct the AC pump 216 to operate orrotate in the clockwise direction to pump anticoagulant 1702 from the ACbag 114 into the anticoagulant tubing 110, as shown in FIGS. 17F and17G. The donor feed tubing 104 may be blocked by a clamp, frangibledevice, or other structure. Thus, the AC 1702 does not flow from thedonor feed tubing 104 to the donor 102. Rather, the AC pump 216 can pushthe anticoagulant 1702 into the cassette inlet tubing 108A, into thesoft cassette 340, and partially into the loop inlet tubing 108B. Inembodiments, the AC 1702 flows through the first bypass branch 358A,second bypass branch 358B, and/or the fluid sensor 316 but notnecessarily into the first tubing section 368A or second tubing section368B. Thus, the cassette microcontroller 1004 can close the first fluidcontrol valve 320A to prevent the AC 1702 from flowing into the firsttubing section 368A, drip chamber 354, or second tubing section 368B.Preplacing the AC 1702 into the first bypass branch 358A, second bypassbranch 358B, and/or the fluid sensor 316 ensures proper flow of wholeblood during the first draw of whole blood from the donor 102 andprevents a large volume of AC 1702 from being returned to the donor 102from the drip chamber 354 when red blood cells are returned later in theprocess.

To determine when to stop the AC pump 216, cassette microcontroller 1004can receive signals from the fluid sensor 316 and/or donor air detectionsensor 312 that indicate fluid is at or is passing the sensors 312, 316.Upon the fluid sensor 316 providing indication to the cassettemicrocontroller 1004 that the AC 1702 has reached the sensor 316, thecassette microcontroller 1004 can continue to direct the AC pump 216 fora predetermined period of time until a known volume of AC 1702 is pumpedthrough the second cassette port 360B and partially into the loop inlettubing 108B. Thus, the priming of the AC 1702 leaves the apheresissystem 200 in a state as shown in FIG. 17G. The status of the variouscomponents of the apheresis system 200, during this step, may be asshown below:

TABLE 5 Prime Anticoagulant Status Prime Anticoagulant Status Flow SpinRate Oc- Open/ Rate Component Name (mL/min) clude? Closed? (RPM) Drawpump 208 0 No Return pump 212 0 Yes Anticoagulant pump 216 30 Plasmaflow control valve 286 Closed Saline flow control valve 288 Closed Firstfluid control valve 320A Closed Second fluid control valve 320B ClosedDraw fluid control valve 320C Open Filler 460 0

In some configurations, the direction of the AC pump 216 may bereversed, as shown in FIG. 17G. At least a portion of the anticoagulant1702 may then be pumped back to the AC bag 114 and/or to a portion ofthe cassette inlet tubing 108A and/or anticoagulant tubing 110. Inembodiments, the cassette microcontroller 1004 can direct the draw fluidcontrol valve 320C to close to maintain the AC in the first bypassbranch 358A, second bypass branch 358B, and/or the fluid sensor 316. Thedonor air detection sensor 312 can determine when the AC 1702 stopspassing the sensor 312 and send a signal to the cassette microcontroller1004. Again, the cassette microcontroller 1004 can continue to directthe AC pump 216 for a predetermined period of time until a known volumeof AC 1702 is pumped back through the cassette inlet tubing 108A. Thus,the AC 1702 leaves the apheresis system 200 in a state as shown in FIG.17H. The amount of anticoagulant left in the cassette inlet tubing 108A,the tubing connector 106, and/or the anticoagulant tubing 110 may bedetermined by the cassette microcontroller 1004 by an amount of timeafter the anticoagulant 1702 passes the donor air detection sensor 312.This process leaves some anticoagulant in cassette inlet tubing 108A butdecreases the amount of AC used to prevent issues with too much AC beingmixed with the incoming whole blood. At this point, the apheresis system200 is prepared and ready to draw whole blood, in phase 1212 (FIG. 12 ).The status of the various components of the apheresis system 200, duringthis step, may be as shown below:

TABLE 6 Prime AC Finish Status Prime AC Finish Status Flow Spin Rate Oc-Open/ Rate Component Name (mL/min) clude? Closed? (RPM) Draw pump 208 0No Return pump 212 0 No Anticoagulant pump 216 −30 Plasma flow controlvalve 286 Closed Saline flow control valve 288 Closed First fluidcontrol valve 320A Open Second fluid control valve 320B Open Draw fluidcontrol valve 320C Closed Filler 460 0

An embodiment of a method 1400, representing the drawing plasma phase1212, may be as shown in FIG. 14 in accordance with embodiments of thepresent disclosure. A general order for the steps of the method 1400 isshown in FIG. 14 . Generally, the method 1400 starts with a startoperation 1404 and ends with operation 1440. The method 1400 can includemore or fewer steps or can arrange the order of the steps differentlythan those shown in FIG. 14 . The method 1400 can be, at leastpartially, executed as a set of computer-executable instructionsexecuted by a computer system, processor, cassette microcontroller 1004,centrifuge microcontroller 1104, and/or other devices and encoded orstored on a computer readable medium. In other configurations, themethod 1400 may be executed, at least partially, by a series ofcomponents, circuits, gates, etc. created in a hardware device, such asa SOC, ASIC, and/or a FPGA. Hereinafter, the method 1400 shall beexplained with reference to the systems, devices, valves, pumps,sensors, components, circuits, modules, software, data structures,signaling processes, models, environments, apheresis systems, methods,etc. described in conjunction with FIGS. 1-13 .

In step 1408, the donor 102 may be stuck with a needle. A phlebotomist,apheresis technician, or other medical professional can attach a needle,having a lumen, to the tubing fitting 504 and place the needle into ablood vessel (e.g., a vein) of the donor 102. Thus, the apheresis system200 may be fluidly connected to the donor 102 and be ready to draw wholeblood. Thus, the apheresis system 200 starts the draw plasma phase 1212in a state with the donor 102 ready to provide whole blood as shown inFIG. 17H. The status of the various components of the apheresis system200, during this step, may be as shown below:

TABLE 7 Stick Donor Status Stick Donor Status Flow Spin Rate Oc- Open/Rate Component Name (mL/min) clude? Closed? (RPM) Draw pump 208 0 YesReturn pump 212 0 Yes Anticoagulant pump 216 0 Plasma flow control valve286 Closed Saline flow control valve 288 Closed First fluid controlvalve 320A Closed Second fluid control valve 320B Closed Draw fluidcontrol valve 320C Closed Filler 460 0

The cassette microcontroller 1004 of the apheresis system 200 can beginto draw whole blood 1706, in step 1412. The cassette microcontroller1004 can direct the AC pump 216, the draw pump 208, and/or the returnpump 212 to operate by rotating in a clockwise rotation. The AC pump 216pushes anticoagulant 1702 towards the plasma collection bottle 122 sothat the AC 1702 mixes with the whole blood 1706 being drawn from thedonor 102 in the tubing connector 106 (and possibly in the donor feedtubing 104) and the other components distal to the tubing connector 106.The draw pump 208 and/or return pump 212 draws whole blood 1706 from thedonor 102 (and AC) into the soft cassette 340, flexible loop 524, and/orblood component collection bladder 536. During this process 1412, thecassette microcontroller 1004 and the centrifuge microcontroller 1008can communicate to inform the centrifuge microcontroller 1008 that thedraw has begun. In response to the indication of the draw beginning, thecentrifuge microcontroller 1008 can instruct the rotor and motorassembly 414 of the centrifuge assembly 400 to begin to rotate or spin.The initial rate of rotation may be slower to allow the blood componentcollection bladder 536 to become seated in the filler insert chamber 492and to draw the whole blood 1706 into the blood component collectionbladder 536. The state of the apheresis system 200, during this step1412, may appear as in FIG. 17I. The status of the various components ofthe apheresis system 200, during this step, may be as shown below:

TABLE 8 Begin Draw Status Begin Draw Status Flow Spin Rate Oc- Open/Rate Component Name (mL/min) clude? Closed? (RPM) Draw pump 208 AF YesReturn pump 212 (AF + 50) Yes Anticoagulant pump 216 AF/15 Plasma flowcontrol valve 286 Open Saline flow control valve 288 Closed First fluidcontrol valve 320A Open Second fluid control valve 320B Open Draw fluidcontrol valve 320C Closed Filler 460 800

In step 1416, the areas of the blood component collection bladder 536adjacent to the channel entrance 468, channel end 472, and/or channelpath jog 476 are primed with whole blood 1706. The cassettemicrocontroller 1004 stops operation of the return pump 212 butcontinues to operate the AC pump 216 and draw pump 208. Whole blood 1706is pushed through the first tubing section 368A, the drip chamber 354,and/or the second tubing section 368B. From the soft cassette 340, thewhole blood 1706 is pushed through the flexible loop 524 and into theblood component collection bladder 536 to the bladder free end 540B. Theanticoagulant pump 216 continues to operate to mix anticoagulant 1702from the anticoagulant bag 114 with the whole blood 1706 drawn from thedonor 102. The apheresis system 200 may appear as shown in FIG. 17Jduring step 1416. The status of the various components of the apheresissystem 200, during this step, may be as shown below:

TABLE 9 Prime Channel Status Prime Channel Status Flow Spi Rate Oc-Open/ n Rate Component Name (mL/min) clude? Closed? (RPM) Draw pump 208AF Yes Return pump 212 0 Yes Anticoagulant pump 216 AF/15 Plasma flowcontrol valve 286 Open Saline flow control valve 288 Closed First fluidcontrol valve 320A Open Second fluid control valve 320B Open Draw fluidcontrol valve 320C Closed Filler 460 3200

Further communication occurs between the cassette microcontroller 1004and the centrifuge microcontroller 1008 to indicate the priming of thechannel. In response to these communications, the centrifugemicrocontroller 1008 directs the rotor and motor assembly 414 of thecentrifuge assembly 400 to begin to rotate or spin at higher revolutionsper minute (RPM).

Referring now to step 1420, the cassette microcontroller 1004 begins toexecute the first draw of plasma 1704 or other blood component from thewhole blood 1706. The cassette microcontroller 1004 continues to operatethe AC pump 216 to provide anticoagulant 1702 into the cassette inlettubing 108A to mix with the whole blood 1706 from the donor 102.Further, the cassette microcontroller 1004 continues to operate the drawpump 208 to move whole blood 1706 into the blood component collectionbladder 536 to separate the plasma 1704 from the whole blood 1706. Togenerate the separation of the plasma 1704, the cassette microcontroller1004 informs the centrifuge microcontroller 1008 that the draw step hasbegun. In response to these communications, the centrifugemicrocontroller 1008 directs the rotor and motor assembly 414 of thecentrifuge assembly 400 to begin to rotate or spin at even higherrevolutions per minute (RPM), e.g., substantially 5,000 RPM, to begin toseparate the red blood cells 1708 from the plasma 1704, as shown in FIG.17K. The draw pump 208 continues to push the plasma 1704 through theflexible loop 524, the system static loop connector 528, and into loopexit tubing 112. The draw process 1420 continues until, at some point,as shown in FIG. 17L, the platelets 1710, separated from the whole blood1706, reach line sensor 812, which signals the cassette microcontroller1004 that the total amount of plasma 1704 from the whole blood 1706pushed into the blood component collection bladder 536 has beenextracted and the cassette microcontroller 1004 moves to step 1424. Thestatus of the various components of the apheresis system 200, duringthis step, may be as shown below:

TABLE 10 Draw Status Draw Status Flow Spin Rate Oc- Open/ Rate ComponentName (mL/min) clude? Closed? (RPM) Draw pump 208 AF Yes Return pump 2120 No Anticoagulant pump 216 AF/15 Plasma flow control valve 286 OpenSaline flow control valve 288 Closed First fluid control valve 320AClosed Second fluid control valve 320B Closed Draw fluid control valve320C Open Filler 460 5000

When platelets 1710, red blood cells, high hematocrit blood, and/orother blood component reach the line sensor 812, determined by thesensor 812 observing a change in color or other characteristic of thefluid, the cassette microcontroller 1004 then determines whether thedonation is complete, in step 1426. A complete donation means the entireamount of plasma 1704 required or desired has been drawn and put intothe plasma collection bottle 122. In embodiments, the cassettemicrocontroller 1004 can determine, whether by weight or volume, if acomplete donation (e.g., 880 mL) has been extracted. This situation maybe as shown in FIG. 17L, where the plasma 1704 has been extracted and isstill present in loop exit tubing 112 and provided to the plasmacollection bottle 122 through plasma tubing 120. If it is an incompletedonation, meaning the plasma collection bottle 122 has not reached itsdesired weight or volume limit, the process 1400 may proceed NO toreturn step 1428. If it is a complete donation, the method 1400 mayproceed YES to the final return step 1432.

In the return step 1428, as depicted in FIG. 17L, the cassettemicrocontroller 1004 instructs the draw pump 208 to stop and reversesthe direction of the return pump 212 to operate in a counterclockwisemotion to push the plasma 1704 from plasma collection bottle 122 throughthe plasma tubing 120, into the loop exit tubing 112, and toward thesoft cassette 340. The cassette microcontroller 1004 further directs thedraw fluid control valve 320C to close and to open both the first fluidcontrol valve 320A and the second fluid control valve 320B. Theseconfiguration changes cause the plasma 1704 to push the red blood cells1708 and the platelets 1710 out of the loop exit tubing 112, theflexible loop 524, the blood component collection bladder 536, throughthe drip chamber 354, and to the donor 102. Importantly, as can be seenin FIG. 17L, the filler 460 continues to rotate at the extraction speed,e.g. 5,000 RPM, during this return step 1428. The system 200 continuesto push red blood cells 1708 back into the donor 102 until thecolor/pressure sensor 808 determines that plasma 1704 has passed throughsensor 808 and may have reached the drip chamber 354, as shown in FIG.17M. At that point, valves 320B and 320A are closed again and the wholeblood 1706 can flow again through the first bypass branch 358A, thesecond bypass branch 358B, and/or the fluid sensor 316. The status ofthe various components of the apheresis system 200, during this step1428, may be as shown below:

TABLE 11 Return Status Return Status Flow Spin Rate Oc- Open/ RateComponent Name (mL/min) clude? Closed? (RPM) Draw pump 208 0 No Returnpump 212 AF Yes Anticoagulant pump 216 0 Plasma flow control valve 286Open Saline flow control valve 288 Closed First fluid control valve 320AOpen Second fluid control valve 320B Open Draw fluid control valve 320CClosed Filler 460 5000

The return step 1428 then moves to a second draw step 1420. The new drawproceeds in a similar fashion to step 1420 described above. However,there is a section of high hematocrit blood that remains in the dripchamber 354. By moving the new flow of whole blood 1706 through thefirst bypass branch 358A, second bypass branch 358B, and/or the fluidsensor 316, less high hematocrit blood is returned to blood componentcollection bladder 536, which red blood cells cannot have more plasma1704 extracted therefrom. Thus, the bypass provided by the soft cassette340 makes the removal of plasma 1704 from whole blood 1706 in the seconddraw step 1420 and subsequent draw steps more efficient.

The return step 1428 and the continued draw step 1420 will repeat forsome number of cycles. The final draw step 1420 may be as shown in FIG.17N. The plasma 1704, within the plasma collection bottle 122, hasreached a desired and/or maximum amount, for example 880 mL, as is shownin FIG. 17N. At this point, a final return is required, in step 1432.The status of the various components of the apheresis system 200, duringthis return step, may be as shown below:

TABLE 12 Final Return Status Final Return Status Flow Spin Rate Oc-Open/ Rate Component Name (mL/min) clude? Closed? (RPM) Draw pump 208 0No Return pump 212 AF Yes Anticoagulant pump 216 0 Plasma flow controlvalve 286 Closed Saline flow control valve 288 Open First fluid controlvalve 320A Open Second fluid control valve 320B Open Draw fluid controlvalve 320C Closed Filler 460 5000

In step 1432, the total amount of plasma 1704 extracted from the donor102 is now in the plasma collection bottle 122, and the apheresis system200 can now push through remaining plasma 1704, red blood cells 1708,and any other blood component into the donor 102. The cassettemicrocontroller 1004 can instruct the plasma flow control valve 286 toclose to maintain the plasma donation in the plasma collection bottle122. The return pump 212 can continue to operate in the counterclockwiserotation to push the red blood cells 1708 and any plasma 1704 or otherblood components back to the donor 102.

After or as part of the final return 1432, the saline 1712 may also bereturned to the donor 102, as shown in FIG. 17O, in step 1436. In thisstep 1436, the cassette microcontroller 1004 opens the saline flowcontrol valve 288 and leaves the first fluid control valve 320A and thesecond fluid control valve 320A open. The return pump 212 continues tooperate in the counterclockwise direction. The centrifugemicrocontroller 1008 stops the filler 460 from rotating. The saline 1712from the saline bag 118 is pushed through the blood component collectionbladder 536, the drip chamber 354, and the various tubing back to thedonor 102. The various blood components left in the blood componentcollection set 500 are pushed back into the donor 102 along with someamount of saline 1712. The saline 1712 helps replenish fluids for thedonor 102 and is required in some jurisdictions. This saline 1712 returncontinues until a predetermined amount of saline 1712 is provided to theuser as determined by the weight or volume of saline 1712 that has leftthe saline bag 118. At this point, as shown in FIG. 17O, the plasmadonation is complete. The status of the various components of theapheresis system 200, during this step, may be as shown below:

TABLE 13 Saline Return Status Saline Return Status Flow Spin Rate Oc-Open/ Rate Component Name (mL/min) clude? Closed? (RPM) Draw pump 208 0No Return pump 212 AF (300) Yes Anticoagulant pump 216 0 Plasma flowcontrol valve 286 Closed Saline flow control valve 288 Open First fluidcontrol valve 320A Open Second fluid control valve 320B Open Draw fluidcontrol valve 320C Open Filler 460 0

An embodiment of a method for unloading the plasma and blood componentcollection set 500 from the apheresis system 200, as described inunloading phase 1216, may be as shown in FIG. 15 , in accordance withembodiments of the present disclosure. A general order for the steps ofthe method 1500 is shown in FIG. 15 . Generally, the method 1500 startswith a start operation 1504 and ends with operation 1528. The method1500 can include more or fewer steps or can arrange the order of thesteps differently than those shown in FIG. 15 . The method 1500 can be,at least partially, executed as a set of computer-executableinstructions executed by a computer system, processor, cassettemicrocontroller 1004, centrifuge microcontroller 1104, and/or otherdevices and encoded or stored on a computer readable medium. In otherconfigurations, the method 1500 may be executed, at least partially, bya series of components, circuits, gates, etc. created in a hardwaredevice, such as a SOC, ASIC, and/or a FPGA. Hereinafter, the method 1500shall be explained with reference to the systems, devices, valves,pumps, sensors, components, circuits, modules, software, datastructures, signaling processes, models, environments, apheresissystems, methods, etc. described in conjunction with FIGS. 1-14 .

The channels are evacuated, in step 1508. In embodiments, the cassettemicrocontroller 1004 operates the draw pump 208 in a counterclockwisedirection to continue to drive saline 1712 substantially completely outof the blood component collection bladder 536 and the rest of the bloodcomponent collection set 500, as shown in FIG. 17P. At some point,substantially the total amount of blood components and/or saline 1712gets pushed back into the donor 102, in which case all pumps 216, 208,and 212 cease operation. The fluid control valve 320A, first fluidcontrol valve 320A, saline flow control valve 288, and any other valvecan then be shut by the cassette microcontroller 1004. At this point,only a minute amount of saline 1712 or no saline at all should remainwithin the blood component collection set 500. The state of theapheresis system 200 may be as shown in FIG. 17Q. The status of thevarious components of the apheresis system 200, during this step, may beas shown below:

TABLE 14 Channel Evacuation Status Channel Evacuation Status Flow SpinRate Oc- Open/ Rate Component Name (mL/min) clude? Closed? (RPM) Drawpump 208 −AF Yes Return pump 212 0 Yes Anticoagulant pump 216 0 Plasmaflow control valve 286 Closed Saline flow control valve 288 Closed Firstfluid control valve 320A Open Second fluid control valve 320B Open Drawfluid control valve 320C Open Filler 460 0

At this point, the blood component collection set 500 can be sealed, instep 1512, as shown in FIG. 17R. The sealing of blood componentcollection set 500 can include clamping the donor feed tubing 104 thatleads to the donor 102 and fusion sealing the tubing at various places.The sealing can be a fusion of the tubes, as the tubes may bethermoplastic, as shown in FIG. 17R. For example, the anticoagulanttubing 110, the saline tubing 116, the plasma tubing 120 (above theplasma flow control valve 286), and the donor feed tubing 104 are allheat fused to separate the AC bag 114, the plasma collection bottle 122,the saline bag 118, and the donor 102 from the rest of the bloodcomponent collection set 500. The status of the various components ofthe apheresis system 200, during this step, may be as shown below:

TABLE 15 Seal Kit Status Seal Kit Status Flow Spin Rate Oc- Open/ RateComponent Name (mL/min) clude? Closed? (RPM) Draw pump 208 0 Yes Returnpump 212 0 Yes Anticoagulant pump 216 0 Plasma flow control valve 286Closed Saline flow control valve 288 Closed First fluid control valve320A Closed Second fluid control valve 320B Closed Draw fluid controlvalve 320C Closed Filler 460 0

At this point, the needle may be taken out of the donor 102, in step1516, as shown in 17R. The status of the various components of theapheresis system 200, during this step, may be as shown below:

TABLE 16 Unstick Donor Status Unstick Donor Status Flow Spin Rate Oc-Open/ Rate Component Name (mL/min) clude? Closed? (RPM) Draw pump 208 0Yes Return pump 212 0 Yes Anticoagulant pump 216 0 Plasma flow controlvalve 286 Closed Saline flow control valve 288 Closed First fluidcontrol valve 320A Closed Second fluid control valve 320B Closed Drawfluid control valve 320C Closed Filler 460 0

The blood component collection set 500 may be unloaded from theapheresis system 200, in step 1520, which entails reversing at leastsome of the procedures described in conjunction with FIGS. 13 and 16 .The status of the various components of the apheresis system 200, duringthis step, may be as shown below:

TABLE 17 Unload Status Unload Status Flow Spin Rate Oc- Open/ RateComponent Name (mL/min) clude? Closed? (RPM) Draw pump 208 0 No Returnpump 212 0 No Anticoagulant pump 216 0 Plasma flow control valve 286Open Saline flow control valve 288 Open First fluid control valve 320AOpen Second fluid control valve 320B Open Draw fluid control valve 320COpen Filler 460 0

Once unloaded, the used blood component collection set 500 can bedisposed of as medical waste. The plasma collection bottle 122 may besealed on plasma tubing 120, as shown in FIG. 17S. The sealed areas maythen prevent any liquid from seeping from the plasma collection bottle122, the saline bag 118, or the anticoagulant bag 114. The plasmacollection bottle 122 may be then be removed and used in whateverprocedure the plasma is required. The rest of the items may be discardedas medical waste and the procedure is completed, in step 1524, as shownin FIG. 17T. The status of the various components of the apheresissystem 200, at the end of the procedure, may be as shown below:

TABLE 18 Complete Procedure Status Complete Procedure Status Flow SpinRate Oc- Open/ Rate Component Name (mL/min) clude? Closed? (RPM) Drawpump 208 0 No Return pump 212 0 No Anticoagulant pump 216 0 Plasma flowcontrol valve 286 Open Saline flow control valve 288 Open First fluidcontrol valve 320A Open Second fluid control valve 320B Open Draw fluidcontrol valve 320C Open Filler 460 0

An embodiment of a method 1600 for inserting a disposable into thefiller of the apheresis system 200 may be as shown in FIG. 16 , inaccordance with embodiments of the present disclosure. A general orderfor the steps of the method 1600 is shown in FIG. 16 . Generally, themethod 1600 starts with a start operation 1604 and ends with operation1632. The method 1600 can include more or fewer steps or can arrange theorder of the steps differently than those shown in FIG. 16 . The method1600 can be, at least partially, executed as a set ofcomputer-executable instructions executed by a computer system,processor, cassette microcontroller 1004, centrifuge microcontroller1104, and/or other devices and encoded or stored on a computer readablemedium. In other configurations, the method 1600 may be executed, atleast partially, by a series of components, circuits, gates, etc.created in a hardware device, such as a SOC, ASIC, and/or a FPGA.Hereinafter, the method 1600 shall be explained with reference to thesystems, devices, valves, pumps, sensors, components, circuits, modules,software, data structures, signaling processes, models, environments,apheresis systems, methods, etc. described in conjunction with FIGS.1-15 .

A filler 460 of an apheresis system 200 may be provided, in step 1608.The filler 460 can be a component of the apheresis system 200 andconfigured to receive at least a portion of the blood componentcollection set 500. In embodiments, the filler 460 is mounted on asplit-housing pivot axis 406 that pivots to expose an internal portionof the upper housing 404B, including the filler 460. A user may pivotthe upper housing 404B to expose the collection insert channel 466 or,in some embodiments, the filler 460 may be automatically pivoted by amotor or other mechanical device. This pivoting and/or loading may be asdescribed in conjunction with FIGS. 4D-4F and/or FIGS. 6A-6C above.

A blood component collection set 500, including a blood componentcollection bladder 536, may be provided, in step 1612. The bloodcomponent collection set 500 may be prepackaged and extracted from thepackaging. A user can expose the blood component collection bladder 536for insertion into the collection insert channel 466, including ensuringthat the bladder free end 540B is positioned at the channel path jog 476of the collection insert channel 466 and the filler loop connector 532is positioned at the loop connection area 454. With the blood componentcollection bladder 536 positioned properly, the user can form the bloodcomponent collection bladder 536 substantially into the shape ofcollection insert channel 466 and the channel path jog 476, in step1616, as shown in FIGS. 5F-5H. Thus, the user can form the bloodcomponent collection bladder 536 generally into a circular shape or anyother shape the generally matches the shape of the collection insertchannel 466.

The user may then insert the formed blood component collection bladder536 into the collection insert channel 466 of the filler 460, as shownin FIGS. 5G and 5H, with the bladder free end 540B of the bloodcomponent collection bladder 536 inset into the channel path jog 476 ofthe collection insert channel 466, in step 1620. The user can insert theblood component collection bladder 536 into the collection insertchannel 466 generally at a central position within filler insert chamber492. Centrifugal forces will generally align the blood componentcollection bladder 536 automatically into the correct position withinthe filler insert chamber 492. However, if not positioned wherecentrifugal forces may act on the blood component collection bladder536, the blood component collection bladder 536 can be ejected from thecollection insert channel 466. Once positioned, the blood componentcollection bladder 536 can be fixed in place.

In step 1624, the user can connect the filler loop connector 532 of theblood component collection bladder 536 to the loop connection area 454of the collection insert channel 466. A mechanical connection may bemade by the user snapping the filler loop connector 532 into the loopconnection area 454. The dimensions and physical features of the fillerinsert chamber 492 can then hold blood component collection bladder 536,with the filler loop connector 532 stable in the loop connection area454, in a stable position allowing the blood component collectionbladder 536 to migrate into the center of the filler insert chamber 492during operation of the centrifuge 400. The portion of the flexible loop524, remaining outside or outboard of the filler 460 can be mounted tothe loop capture arm 416. This mounting of the flexible loop 524 allowsfor the 1ω/2ω action of the centrifuge 400.

After the flexible loop 524 is mounted, the upper housing 404B may beflipped into position, in step 1628. Thus, the filler 460 may be pivotedby the hinge axis 406 (e.g., hinge, etc.) into the interior of thesystem housing 204. The centrifuge housing 404 may then be rotated withblood component collection loop 520 passing through a loop accessclearance 436 in the centrifuge split-housing 404. When the bloodcomponent collection loop 520 is loaded in the loop loading position520A, a portion of the blood component collection loop 520 may bepartially contained, held, and/or supported by a loop containmentbracket 426, as described in conjunction with FIGS. 4A-4C. The accesspanel 224 may be pivoted into the closed position allowing for theoperation of the system 200.

The exemplary systems and methods of this disclosure have been describedin relation to apheresis methods and systems. However, to avoidunnecessarily obscuring the present disclosure, the precedingdescription omits a number of known structures and devices. Thisomission is not to be construed as a limitation of the scope of theclaimed disclosure. Specific details are set forth to provide anunderstanding of the present disclosure. It should, however, beappreciated that the present disclosure may be practiced in a variety ofways beyond the specific detail set forth herein.

Furthermore, while the exemplary aspects, embodiments, and/orconfigurations illustrated herein show the various components of thesystem collocated, certain components of the system can be locatedremotely, at distant portions of a distributed network, such as a LANand/or the Internet, or within a dedicated system. Thus, it should beappreciated, that the components of the system can be combined into oneor more devices, such as the cassette node 904 and the centrifuge node908, or collocated on a particular node of a distributed network, suchas an analog and/or digital telecommunications network, a packet-switchnetwork, or a circuit-switched network. It will be appreciated from thepreceding description, and for reasons of computational efficiency, thatthe components of the system can be arranged at any location within adistributed network of components without affecting the operation of thesystem. For example, the various components can be located in a switchsuch as a PBX and media server, gateway, in one or more communicationsdevices, at one or more users' premises, or some combination thereof.Similarly, one or more functional portions of the system could bedistributed between a telecommunications device(s) and an associatedcomputing device.

Furthermore, it should be appreciated that the various links connectingthe elements can be wired or wireless links, or any combination thereof,or any other known or later developed element(s) that is capable ofsupplying and/or communicating data to and from the connected elements.These wired or wireless links can also be secure links and may becapable of communicating encrypted information. Transmission media usedas links, for example, can be any suitable carrier for electricalsignals, including coaxial cables, copper wire and fiber optics, and maytake the form of acoustic or light waves, such as those generated duringradio-wave and infra-red data communications.

Also, while the flowcharts have been discussed and illustrated inrelation to a particular sequence of events, it should be appreciatedthat changes, additions, and omissions to this sequence can occurwithout materially affecting the operation of the disclosed embodiments,configuration, and aspects.

A number of variations and modifications of the disclosure can be used.It would be possible to provide for some features of the disclosurewithout providing others.

In yet another embodiment, the systems and methods of this disclosurecan be implemented in conjunction with a special purpose computer, aprogrammed microprocessor or microcontroller and peripheral integratedcircuit element(s), an ASIC or other integrated circuit, a digitalsignal processor, a hard-wired electronic or logic circuit such asdiscrete element circuit, a programmable logic device or gate array suchas PLD, PLA, FPGA, PAL, special purpose computer, any comparable means,or the like. In general, any device(s) or means capable of implementingthe methodology illustrated herein can be used to implement the variousaspects of this disclosure. Exemplary hardware that can be used for thedisclosed embodiments, configurations and aspects includes computers,handheld devices, telephones (e.g., cellular, Internet enabled, digital,analog, hybrids, and others), and other hardware known in the art. Someof these devices include processors (e.g., a single or multiplemicroprocessors), memory, nonvolatile storage, input devices, and outputdevices. Furthermore, alternative software implementations including,but not limited to, distributed processing or component/objectdistributed processing, parallel processing, or virtual machineprocessing can also be constructed to implement the methods describedherein.

In yet another embodiment, the disclosed methods may be readilyimplemented in conjunction with software using object or object-orientedsoftware development environments that provide portable source code thatcan be used on a variety of computer or workstation platforms.Alternatively, the disclosed system may be implemented partially orfully in hardware using standard logic circuits or VLSI design. Whethersoftware or hardware is used to implement the systems in accordance withthis disclosure is dependent on the speed and/or efficiency requirementsof the system, the particular function, and the particular software orhardware systems or microprocessor or microcomputer systems beingutilized.

In yet another embodiment, the disclosed methods may be partiallyimplemented in software that can be stored on a storage medium, executedon programmed general-purpose computer with the cooperation of acontroller and memory, a special purpose computer, a microprocessor, orthe like. In these instances, the systems and methods of this disclosurecan be implemented as program embedded on personal computer such as anapplet, JAVA® or CGI script, as a resource residing on a server orcomputer workstation, as a routine embedded in a dedicated measurementsystem, system component, or the like. The system can also beimplemented by physically incorporating the system and/or method into asoftware and/or hardware system.

Although the present disclosure describes components and functionsimplemented in the aspects, embodiments, and/or configurations withreference to particular standards and protocols, the aspects,embodiments, and/or configurations are not limited to such standards andprotocols. Other similar standards and protocols not mentioned hereinare in existence and are considered to be included in the presentdisclosure. Moreover, the standards and protocols mentioned herein andother similar standards and protocols not mentioned herein areperiodically superseded by faster or more effective equivalents havingessentially the same functions. Such replacement standards and protocolshaving the same functions are considered equivalents included in thepresent disclosure.

The present disclosure, in various aspects, embodiments, and/orconfigurations, includes components, methods, processes, systems and/orapparatus substantially as depicted and described herein, includingvarious aspects, embodiments, configurations embodiments,subcombinations, and/or subsets thereof. Those of skill in the art willunderstand how to make and use the disclosed aspects, embodiments,and/or configurations after understanding the present disclosure. Thepresent disclosure, in various aspects, embodiments, and/orconfigurations, includes providing devices and processes in the absenceof items not depicted and/or described herein or in various aspects,embodiments, and/or configurations hereof, including in the absence ofsuch items as may have been used in previous devices or processes, e.g.,for improving performance, achieving ease and\or reducing cost ofimplementation.

The foregoing discussion has been presented for purposes of illustrationand description. The foregoing is not intended to limit the disclosureto the form or forms disclosed herein. In the foregoing DetailedDescription for example, various features of the disclosure are groupedtogether in one or more aspects, embodiments, and/or configurations forthe purpose of streamlining the disclosure. The features of the aspects,embodiments, and/or configurations of the disclosure may be combined inalternate aspects, embodiments, and/or configurations other than thosediscussed above. This method of disclosure is not to be interpreted asreflecting an intention that the claims require more features than areexpressly recited in each claim. Rather, as the following claimsreflect, inventive aspects lie in less than all features of a singleforegoing disclosed aspect, embodiment, and/or configuration. Thus, thefollowing claims are hereby incorporated into this Detailed Description,with each claim standing on its own as a separate preferred embodimentof the disclosure.

Moreover, though the description has included description of one or moreaspects, embodiments, and/or configurations and certain variations andmodifications, other variations, combinations, and modifications arewithin the scope of the disclosure, e.g., as may be within the skill andknowledge of those in the art, after understanding the presentdisclosure. It is intended to obtain rights which include alternativeaspects, embodiments, and/or configurations to the extent permitted,including alternate, interchangeable and/or equivalent structures,functions, ranges or steps to those claimed, whether or not suchalternate, interchangeable and/or equivalent structures, functions,ranges or steps are disclosed herein, and without intending to publiclydedicate any patentable subject matter.

What is claimed is:
 1. A system for controlling a soft cassette assemblyof an apheresis machine, the system comprising: at least one processor;and at least one memory storing instructions that, when executed by theat least one processor, cause the system to receive at least one signalfrom at least one sensor of the soft cassette assembly; actuate at leastone valve of the soft cassette assembly based on the at least one signalreceived from the at least one sensor; and actuate at least one pumpbased on the at least one signal received from the at least one sensor.2. The system of claim 1, wherein the at least one sensor comprises atleast one of an air detection sensor, a fluid sensor, or a pressuresensor.
 3. The system of claim 1, wherein the at least one valvecomprises a fluid control valve configured to prevent fluid flow throughthe soft cassette assembly when closed and configured to allow fluidflow through the soft cassette assembly when open.
 4. The system ofclaim 1, wherein the actuating the at least one valve of the softcassette assembly includes actuating the at least one valve to a closedposition to redirect fluid from a first fluid path to a second fluidpath of the soft cassette assembly.
 5. The system of claim 4, whereinthe first fluid path is through a direct flow lumen of the soft cassetteassembly and the second fluid path is a fluid flow bypass path of thesoft cassette assembly.
 6. The system of claim 1, wherein the at leastone pump is a draw pump, a return pump, or an anticoagulant pump of theapheresis machine.
 7. A system for controlling a centrifuge of anapheresis machine, the system comprising: at least one processor; and atleast one memory storing instructions that, when executed by the atleast one processor, cause the system to receive at least one signalfrom at least one sensor of the centrifuge; actuate a motor of thecentrifuge to rotate the centrifuge at a desired speed setting; andactuate a brake of the centrifuge based on the at least one signalreceived from the at least one sensor.
 8. The system of claim 7, whereinthe processor is further configured to cause the system to set apressure of a pressure cuff configured to be placed around a donor's armduring operation of the apheresis machine.
 9. The system of claim 7,wherein the processor is further configured to cause the system toactuate a strobe light of the apheresis machine.
 10. The system of claim9, wherein the strobe light is configured to flash at a periodicity insynchronicity with a rate of spin of the centrifuge.
 11. The system ofclaim 9, wherein the processor is further configured to cause the systemto adjust at least one of a frequency of flashing of the strobe light oran intensity of light of the strobe light.
 12. The system of claim 7,wherein the at least one sensor comprises at least one of an airdetection sensor, a fluid sensor, or a pressure sensor.
 13. A system forcontrolling an apheresis machine, the system comprising: a soft cassetteassembly system including at least one first processor; and at least onefirst memory storing instructions that, when executed by the at leastone first processor, cause the soft cassette assembly system to receiveat least one signal from at least one cassette sensor, actuate at leastone valve of the soft cassette assembly based on the at least one signalreceived from the at least one cassette sensor, and actuate at least onepump based on the at least one signal received from the at least onecassette sensor, and a centrifuge system including at least one secondprocessor; and at least one second memory storing instructions that,when executed by the at least one processor, cause the centrifuge systemto receive at least one signal from at least one centrifuge sensor,actuate a motor of the centrifuge to rotate the centrifuge at a desiredspeed setting, and actuate a brake of the centrifuge based on the atleast one signal received from the at least one centrifuge sensor, andwherein the soft cassette assembly system and the centrifuge system areconfigured to communicate.
 14. The system of claim 13, wherein the softcassette assembly system and the centrifuge system are configured tocommunicate wirelessly or through a wired connection.
 15. The system ofclaim 13, wherein the at least one cassette sensor and the at least onecentrifuge sensor comprise at least one of an air detection sensor, afluid sensor, or a pressure sensor.
 16. The system of claim 13, whereinthe at least one valve comprises a fluid control valve configured toprevent fluid flow through the soft cassette assembly when closed andconfigured to allow fluid flow through the soft cassette assembly whenopen.
 17. The system of claim 13, wherein the actuating the at least onevalve of the soft cassette assembly includes actuating the at least onevalve to a closed position to redirect fluid from a first fluid path toa second fluid path of the soft cassette assembly.
 18. The system ofclaim 13, wherein the second processor is further configured to causethe centrifuge system to set a pressure of a pressure cuff configured tobe placed around a donor's arm during operation of the apheresismachine.
 19. The system of claim 13, wherein the second processor isfurther configured to cause the centrifuge system to actuate a strobelight of the apheresis machine.
 20. The system of claim 19, wherein thesecond processor is further configured to cause the centrifuge system toadjust at least one of a frequency of flashing of the strobe light or anintensity of light of the strobe light.